Trial Outcomes & Findings for Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma (NCT NCT05064358)

NCT ID: NCT05064358

Last Updated: 2025-10-07

Results Overview

The KVA scale is based on the evaluation of corneal changes using slit lamp examination. This scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 177 participants
• Primary outcome timeframe: Up to 29.5 months
• Results posted on: 2025-10-07

Participant Flow

The results presented are based on the data cut-off date of 30 Jan 2025. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in the Post Analysis Continuation of Treatment (PACT) phase. Additional safety results will be provided within one year of study completion.

Participant milestones

Measure	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Overall Study STARTED	40	40	40	40	17
Overall Study Safety	39	40	39	40	17
Overall Study Pharmacokinetic	38	41	39	40	17
Overall Study COMPLETED	10	7	8	9	7
Overall Study NOT COMPLETED	30	33	32	31	10

Reasons for withdrawal

Measure	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Overall Study Death	23	23	25	21	5
Overall Study Lost to Follow-up	1	2	0	2	0
Overall Study Physician Decision	1	1	2	0	0
Overall Study Withdrawal by Subject	4	5	3	6	3
Overall Study Ongoing at the time of analysis	1	2	2	2	2

Baseline Characteristics

Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Measure	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=40 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=40 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Total n=177 Participants Total of all reporting groups
Age, Continuous	66.6 YEARS STANDARD_DEVIATION 10.36 • n=5 Participants	63.0 YEARS STANDARD_DEVIATION 9.02 • n=7 Participants	63.7 YEARS STANDARD_DEVIATION 9.92 • n=5 Participants	65.4 YEARS STANDARD_DEVIATION 8.87 • n=4 Participants	67.1 YEARS STANDARD_DEVIATION 10.42 • n=21 Participants	64.9 YEARS STANDARD_DEVIATION 9.66 • n=8 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	21 Participants n=7 Participants	19 Participants n=5 Participants	16 Participants n=4 Participants	8 Participants n=21 Participants	83 Participants n=8 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants	24 Participants n=4 Participants	9 Participants n=21 Participants	94 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latino	13 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	46 Participants n=8 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	27 Participants n=5 Participants	31 Participants n=7 Participants	28 Participants n=5 Participants	34 Participants n=4 Participants	11 Participants n=21 Participants	131 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 29.5 months

Population: Safety Population included all randomized participants who received at least 1 dose of study treatment. As outlined in the protocol, the objective was to examine the corneal events in Arms B to D, compared to Arm A; hence, Arm E was not included.

The KVA scale is based on the evaluation of corneal changes using slit lamp examination. This scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=39 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale	—	64 Percentage of participants	40 Percentage of participants	44 Percentage of participants	38 Percentage of participants

SECONDARY outcome

Timeframe: Up to week 16

Population: Safety Population.

The number of participants with corneal events were assessed using KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=39 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Number of Participants With Corneal Events up to Week 16	12 Participants	26 Participants	25 Participants	23 Participants	24 Participants

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population. Only those participants with data available at specified time points have been analyzed.

Incidence rate of corneal events is defined as the percentage of participants with corneal events by grade according to the KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=12 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=39 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Incidence Rate of Corneal Events by Grade (KVA Scale) Grade 1	2 Percentage of participants	3 Percentage of participants	10 Percentage of participants	7 Percentage of participants	10 Percentage of participants
Incidence Rate of Corneal Events by Grade (KVA Scale) Grade 2	3 Percentage of participants	10 Percentage of participants	4 Percentage of participants	5 Percentage of participants	6 Percentage of participants
Incidence Rate of Corneal Events by Grade (KVA Scale) Grade 3	6 Percentage of participants	15 Percentage of participants	9 Percentage of participants	11 Percentage of participants	9 Percentage of participants
Incidence Rate of Corneal Events by Grade (KVA Scale) Grade 4	2 Percentage of participants	0 Percentage of participants	3 Percentage of participants	1 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population

Exposure adjusted incidence rate of corneal events is defined as the number of participants with corneal events divided by the total exposure time for all participants at risk in the treatment group. Incidence rate for corneal events was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity. The number of participants with Grades 3,4, and 5 are presented.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=39 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade Grade 3	3 Events per 100 patient years	4 Events per 100 patient years	2 Events per 100 patient years	4 Events per 100 patient years	0 Events per 100 patient years
Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade Grade 4	0 Events per 100 patient years	0 Events per 100 patient years	0 Events per 100 patient years	0 Events per 100 patient years	0 Events per 100 patient years
Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade Grade 5	0 Events per 100 patient years	0 Events per 100 patient years	0 Events per 100 patient years	0 Events per 100 patient years	0 Events per 100 patient years

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population

Median duration of dose delays is defined as the median duration in time of all the dose delays in the respective treatment group. Duration of delays is defined as period from the expected start date of dose to actual start date of current dose.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=39 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Median Duration of All the Dose Delays	59.0 Days Interval 25.0 to 88.0	39.0 Days Interval 16.0 to 144.0	18.0 Days Interval 4.0 to 125.0	51.0 Days Interval 18.0 to 163.0	60.0 Days Interval 34.0 to 103.0

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population. Only those participants who experienced corneal events have been analyzed.

The percentage of participants that required dose reduction, dose interruption/delay, permanent treatment discontinuation due to corneal events were evaluated using KVA Scale. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=12 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=26 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=25 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=23 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=24 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events Dose Reduction	35 Percentage of participants	31 Percentage of participants	28 Percentage of participants	26 Percentage of participants	23 Percentage of participants
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events Dose Interruption/Delay	29 Percentage of participants	59 Percentage of participants	35 Percentage of participants	28 Percentage of participants	33 Percentage of participants
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events Permanent Treatment Discontinuation	6 Percentage of participants	0 Percentage of participants	3 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: At 3 months, 6 months, 9 months and 12 months

Population: Safety Population. Only those participants who experienced corneal events (KVA scale) of Grade 2 or above have been analyzed.

Cumulative incidence of Grade 2 or above corneal events is defined as the percentage of corneal events of Grade 2 or above, as assessed using the KVA scale, within a specific time interval. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=11 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=25 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=16 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=17 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=15 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) At 12 months	59 Percentage of events	64 Percentage of events	40 Percentage of events	44 Percentage of events	38 Percentage of events
Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) At 3 months	53 Percentage of events	59 Percentage of events	32 Percentage of events	36 Percentage of events	33 Percentage of events
Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) At 6 months	59 Percentage of events	64 Percentage of events	37 Percentage of events	41 Percentage of events	38 Percentage of events
Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) At 9 months	59 Percentage of events	64 Percentage of events	40 Percentage of events	41 Percentage of events	38 Percentage of events

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population

Toxicity Index is a composite score derived from the severity grades of adverse events (AEs) reported during the study, based on the Common Terminology Criteria for Adverse Events (CTCAE). A participant's score is calculated as a function of the ordered toxicity grades, represented in descending order by sequence, on a scale of 0-6, where 0 represents no toxicity and 6 represents the highest toxicity. CTCAE grades are defined as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences), and Grade 5 (Death related to AE). Higher grades indicate greater toxicity severity.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=39 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Toxicity Index (TI)	3.64 Score on scale Standard Deviation 0.892	3.68 Score on scale Standard Deviation 1.078	3.83 Score on scale Standard Deviation 1.017	3.87 Score on scale Standard Deviation 1.092	3.43 Score on scale Standard Deviation 1.031

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population. Only those participants who experienced corneal events (KVA Scale) of Grade 2 or above have been analyzed.

Duration of corneal events is defined for each participant as the sum of duration of all the corneal AEs. The duration is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first time resolution to baseline, Grade 1 or below. It required at least one day gap between the resolution of all events from first occurrence to the onset of next occurrence.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=11 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=25 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=16 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=17 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=15 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Duration of Corneal Events of Grade 2 or Above	44.0 Days Interval 21.0 to 274.0	63.0 Days Interval 22.0 to 296.0	67.5 Days Interval 13.0 to 233.0	46.5 Days Interval 20.0 to 162.0	53.5 Days Interval 20.0 to 148.0

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population. Only those participants who experienced corneal events of Grade 2 or above have been analyzed.

It is defined as the percentage of time that a participant has corneal events out of the total time that a participant is on the study. Time with corneal events is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first-time resolution to baseline, Grade 1 or below.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=11 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=25 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=16 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=17 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=15 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Percentage of Time on Study With Grade 2 or Above Corneal Events	35.63 Percentage of Time Interval 3.9 to 61.6	23.27 Percentage of Time Interval 0.5 to 76.7	24.86 Percentage of Time Interval 5.1 to 69.1	18.99 Percentage of Time Interval 0.4 to 78.1	23.67 Percentage of Time Interval 5.5 to 85.6

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 152 weeks

Population: Safety Population. Only those participants with data available at specified time points have been analyzed.

Change in BCVA is defined as change in logarithm of the minimum angle of resolution (logMAR) units compared with baseline or the first visit after the cataract surgery. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any change from baseline categories is presented for right and left eyes. No change/improved vision is defined as a change from baseline <0.1; a possible worsened vision is defined as a change from baseline >=0.1 to <=0.3; a definite worsened vision is defined as a change from baseline >0.3 logMAR score. Improvement in BCVA is represented by a reduction in logMAR score from baseline, while worsening in BCVA is represented by an increase in logMAR score from baseline.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=11 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=22 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=24 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=23 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=29 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores Left Eye · No change	8 Participants	16 Participants	20 Participants	19 Participants	27 Participants
Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores Left Eye · Possible worsened vision	1 Participants	2 Participants	3 Participants	3 Participants	1 Participants
Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores Left Eye · Definite worsened vision	2 Participants	4 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores Right Eye · No change	10 Participants	16 Participants	18 Participants	21 Participants	27 Participants
Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores Right Eye · Possible worsened vision	1 Participants	4 Participants	5 Participants	2 Participants	2 Participants
Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores Right Eye · Definite worsened vision	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Intent-to-Treat Population included all randomized participants, whether or not randomized treatment was administered.

ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=40 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=40 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Objective Response Rate (ORR)	18 Percentage of participants Interval 3.8 to 43.4	33 Percentage of participants Interval 18.6 to 49.1	25 Percentage of participants Interval 12.7 to 41.2	28 Percentage of participants Interval 14.6 to 43.9	25 Percentage of participants Interval 12.7 to 41.2

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Intent-to-Treat Population

Percentage of participants with a confirmed VGPR or better defined as percentage of participant with confirmed VGPR, CR, and sCR, according to the 2016 IMWG response criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=40 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=40 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR)	18 Percentage of participants Interval 3.8 to 43.4	25 Percentage of participants Interval 12.7 to 41.2	18 Percentage of participants Interval 7.3 to 32.8	8 Percentage of participants Interval 1.6 to 20.4	15 Percentage of participants Interval 5.7 to 29.8

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Intent-to-Treat Population. Only those participants with confirmed partial response (PR) or better (i.e., PR, VGPR, CR and sCR) have been analyzed.

TTR defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better), according to the 2016 IMWG response criteria. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=3 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=13 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=10 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=11 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=10 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Time to Response (TTR)	1.5 Months Interval 0.8 to The upper limit of the 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events	0.8 Months Interval 0.7 to 1.4	1.1 Months Interval 0.7 to 2.1	0.7 Months Interval 0.7 to 0.9	0.8 Months Interval 0.7 to 2.2

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Intent-to-Treat Population. Only those participants with confirmed PR or better (i.e., PR, VGPR, CR and sCR) have been analyzed.

DoR defined as the time from first documented evidence of PR or better until disease progression (PD) among responders according to the 2016 IMWG response criteria or death due to any cause. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=3 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=13 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=10 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=11 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=10 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Duration of Response (DoR)	15.9 Months The lower and upper limit 95% confidence interval were not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events	15.9 Months Interval 4.9 to 21.4	22.1 Months Interval 4.2 to The upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events	6.2 Months Interval 2.1 to 20.7	7.8 Months Interval 2.8 to 13.3

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Intent-to-Treat Population. Only those participants with documented PD or death due to PD have been analyzed.

TTP defined as the time from randomization until the earliest date of documented PD or death due to PD, according to the 2016 IMWG response criteria. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=10 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=26 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=29 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=28 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=32 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Time to Progression (TTP)	2.9 Months Interval 0.8 to 17.3	6.0 Months Interval 2.8 to 10.4	2.1 Months Interval 1.0 to 9.1	2.8 Months Interval 1.7 to 4.2	2.7 Months Interval 1.9 to 5.6

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Intent-to-Treat Population. Only those participants with documented PD or death due to any cause have been analyzed.

PFS defined as the time from randomization until the earliest date of documented PD, according to the 2016 IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=11 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=29 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=30 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=30 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=34 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Progression Free Survival (PFS)	2.8 Months Interval 0.8 to 17.3	5.7 Months Interval 2.8 to 9.0	2.1 Months Interval 1.0 to 3.6	2.8 Months Interval 1.4 to 3.5	2.7 Months Interval 1.9 to 4.2

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Intent-to-Treat Population. Only those participants with documented death due to any cause have been analyzed.

OS defined as the time from randomization until the date of death due to any cause.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=5 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=23 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=23 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=25 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=21 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Overall Survival (OS)	NA Months Interval 4.8 to The median and upper limit 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.	20.9 Months Interval 8.1 to The upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.	15.0 Months Interval 7.6 to 20.1	13.5 Months Interval 7.5 to 21.2	14.5 Months Interval 7.7 to The upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs were coded using the standard Medical Dictionary for Regulatory Activities (MedDRA).

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=39 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Percentage of Participants With AEs	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population

Percentage of participants requiring dose reduction, dose interruption/delay, permanent treatment discontinuation due to any AEs were presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs were coded using the standard MedDRA.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=39 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs Dose Reduction	18 Percentage of participants	8 Percentage of participants	13 Percentage of participants	5 Percentage of participants	5 Percentage of participants
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs Dose Interruption/Delay	35 Percentage of participants	31 Percentage of participants	23 Percentage of participants	13 Percentage of participants	10 Percentage of participants
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs Permanent Treatment Discontinuation	18 Percentage of participants	10 Percentage of participants	8 Percentage of participants	10 Percentage of participants	5 Percentage of participants

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population. Only those participants with data available for specified categories have been analyzed. Participants were counted more than once within some categories, so the percentages may not add to 100 percent (%).

Blood samples were collected for the analysis of hematology parameters. The parameters were graded according to CTCAE grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=16 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=38 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=39 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=38 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Eosinophilia, Increase to Grades 1 to 4	0 Participants	3 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Eosinophilia, Increase to Grades 2 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Anemia, Increase to Grades 2 to 4	5 Participants	16 Participants	14 Participants	17 Participants	14 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hemoglobin increased, Increase to Grades 2 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hemoglobin increased, Increase to Grades 3 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Leukocytosis, Increase to Grades 2 to 4	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Leukocytosis, Increase to Grades 3 to 4	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline White blood cell decreased, Increase to Grades 3 to 4	4 Participants	9 Participants	7 Participants	5 Participants	6 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Lymphocyte count decreased, Increase to Grades 3 to 4	1 Participants	6 Participants	4 Participants	4 Participants	4 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Neutrophil count decreased, Increase to Grades 1 to 4	5 Participants	15 Participants	12 Participants	12 Participants	9 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Neutrophil count decreased, Increase to Grades 3 to 4	4 Participants	5 Participants	4 Participants	2 Participants	3 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Platelet count decreased, Increase to Grades 1 to 4	7 Participants	24 Participants	30 Participants	23 Participants	21 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Platelet count decreased, Increase to Grades 3 to 4	4 Participants	9 Participants	13 Participants	10 Participants	9 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Eosinophilia, Increase to Grades 3 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Anemia, Increase to Grades 1 to 4	6 Participants	17 Participants	15 Participants	20 Participants	15 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Anemia, Increase to Grades 3 to 4	4 Participants	10 Participants	9 Participants	11 Participants	9 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hemoglobin increased, Increase to Grades 1 to 4	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Leukocytosis, Increase to Grades 1 to 4	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline White blood cell decreased, Increase to Grades 1 to 4	9 Participants	22 Participants	17 Participants	18 Participants	19 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline White blood cell decreased, Increase to Grades 2 to 4	6 Participants	17 Participants	13 Participants	13 Participants	9 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Lymphocyte count decreased, Increase to Grades 1 to 4	6 Participants	18 Participants	13 Participants	15 Participants	6 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Lymphocyte count decreased, Increase to Grades 2 to 4	3 Participants	11 Participants	7 Participants	9 Participants	5 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Lymphocyte count increased, Increase to Grades 1 to 4	0 Participants	2 Participants	2 Participants	3 Participants	4 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Lymphocyte count increased, Increase to Grades 2 to 4	0 Participants	2 Participants	2 Participants	3 Participants	4 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Lymphocyte count increased, Increase to Grades 3 to 4	0 Participants	2 Participants	2 Participants	1 Participants	3 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Neutrophil count decreased, Increase to Grades 2 to 4	4 Participants	10 Participants	7 Participants	6 Participants	7 Participants
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Platelet count decreased, Increase to Grades 2 to 4	5 Participants	15 Participants	20 Participants	12 Participants	13 Participants

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population. Only those participants with data available for specified categories have been analyzed. Participants were counted more than once within some categories, so the percentages may not add to 100 percent (%)

Blood samples were collected for the analysis of clinical chemistry parameters. The parameters were graded according to CTCAE grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=15 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=38 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=38 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=37 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline CPK increased, Increase to Grades 3 to 4	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Alanine aminotransferase increased, Increase to Grades 3 to 4	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Alanine aminotransferase increased, Increase to Grades 1 to 4	2 Participants	9 Participants	14 Participants	12 Participants	9 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Alanine aminotransferase increased, Increase to Grades 2 to 4	0 Participants	2 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Aspartate aminotransferase increased, Increase to Grades 2 to 4	0 Participants	4 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Blood bilirubin increased, Increase to Grades 1 to 4	3 Participants	4 Participants	4 Participants	4 Participants	3 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Blood bilirubin increased, Increase to Grades 2 to 4	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypercalcemia, Increase to Grades 1 to 4	4 Participants	14 Participants	13 Participants	15 Participants	12 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypercalcemia, Increase to Grades 2 to 4	1 Participants	3 Participants	2 Participants	5 Participants	3 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypocalcemia, Increase to Grades 1 to 4	6 Participants	12 Participants	16 Participants	8 Participants	10 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypocalcemia, Increase to Grades 2 to 4	1 Participants	3 Participants	4 Participants	3 Participants	2 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypocalcemia, Increase to Grades 3 to 4	0 Participants	1 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline CPK increased, Increase to Grades 1 to 4	2 Participants	11 Participants	8 Participants	5 Participants	6 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline CPK increased, Increase to Grades 2 to 4	0 Participants	5 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Creatinine increased, Increase to Grades 1 to 4	7 Participants	14 Participants	18 Participants	18 Participants	15 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Creatinine increased, Increase to Grades 2 to 4	2 Participants	6 Participants	9 Participants	6 Participants	7 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Creatinine increased, Increase to Grades 3 to 4	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Chronic Kidney Disease, Increase to Grades 1 to 4	4 Participants	6 Participants	8 Participants	8 Participants	8 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Chronic Kidney Disease, Increase to Grades 2 to 4	4 Participants	6 Participants	6 Participants	8 Participants	8 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Chronic Kidney Disease, Increase to Grades 3 to 4	2 Participants	3 Participants	3 Participants	1 Participants	3 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline GGT increased, Increase to Grades 1 to 4	5 Participants	17 Participants	16 Participants	16 Participants	9 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline GGT increased, Increase to Grades 2 to 4	1 Participants	10 Participants	7 Participants	3 Participants	7 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline GGT increased, Increase to Grades 3 to 4	0 Participants	2 Participants	3 Participants	1 Participants	3 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Blood lactate dehydrogenase increased, Increase to Grades 1 to 4	6 Participants	20 Participants	19 Participants	19 Participants	15 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Blood lactate dehydrogenase increased, Increase to Grades 2 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Blood lactate dehydrogenase increased, Increase to Grades 3 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypermagnesemia, Increase to Grades 2 to 4	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypomagnesemia, Increase to Grades 2 to 4	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hyperkalemia, Increase to Grades 1 to 4	2 Participants	4 Participants	6 Participants	7 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hyperkalemia, Increase to Grades 2 to 4	0 Participants	1 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypermagnesemia, Increase to Grades 1 to 4	0 Participants	2 Participants	3 Participants	3 Participants	2 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypermagnesemia, Increase to Grades 3 to 4	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypomagnesemia, Increase to Grades 1 to 4	2 Participants	7 Participants	3 Participants	5 Participants	8 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypomagnesemia, Increase to Grades 3 to 4	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hyperkalemia, Increase to Grades 3 to 4	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypernatremia, Increase to Grades 1 to 4	3 Participants	4 Participants	4 Participants	3 Participants	5 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypernatremia, Increase to Grades 2 to 4	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypernatremia, Increase to Grades 3 to 4	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypoalbuminemia, Increase to Grades 1 to 4	7 Participants	19 Participants	15 Participants	14 Participants	13 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypoalbuminemia, Increase to Grades 2 to 4	2 Participants	6 Participants	9 Participants	11 Participants	6 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypoalbuminemia, Increase to Grades 3 to 4	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Alkaline phosphatase increased, Increase to Grades 1 to 4	3 Participants	10 Participants	15 Participants	8 Participants	9 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Alkaline phosphatase increased, Increase to Grades 2 to 4	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Alkaline phosphatase increased, Increase to Grades 3 to 4	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Aspartate aminotransferase increased, Increase to Grades 1 to 4	3 Participants	20 Participants	23 Participants	22 Participants	14 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Aspartate aminotransferase increased, Increase to Grades 3 to 4	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Blood bilirubin increased, Increase to Grades 3 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Hypercalcemia, Increase to Grades 3 to 4	1 Participants	3 Participants	1 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 152 weeks

Population: Safety Population. Only those participants with data available at specified time points have been analyzed.

Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=15 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=37 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=37 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=32 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=36 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 152 weeks

Population: Safety Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.

Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle(C)1 Day(D) 1 Pre-dose, End of Infusion (EOI), Start of Infusion (SOI) + 2 hours (H); C1D2 SOI+24H; C1D4; C1D8-15

Population: Pharmacokinetic (PK) Population included all participants in the Safety Population from whom at least 1 post-treatment PK sample was obtained and analyzed. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.

Plasma samples were collected for PK analysis for belantamab mafodotin antibody-drug conjugate (ADC).

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=38 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=41 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC)	34.1 Microgram/ millilitre (ug/mL) Geometric Coefficient of Variation 26.8	44.8 Microgram/ millilitre (ug/mL) Geometric Coefficient of Variation 22.8	33.1 Microgram/ millilitre (ug/mL) Geometric Coefficient of Variation 23.2	42.1 Microgram/ millilitre (ug/mL) Geometric Coefficient of Variation 24.7	33.1 Microgram/ millilitre (ug/mL) Geometric Coefficient of Variation 18.3

SECONDARY outcome

Timeframe: At 21 days

Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.

Plasma samples were collected for PK analysis for belantamab mafodotin ADC.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=38 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=41 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Concentration at 21 Days for Belantamab Mafodotin ADC	1.53 ug/mL Geometric Coefficient of Variation 62.1	2.28 ug/mL Geometric Coefficient of Variation 56.7	1.5 ug/mL Geometric Coefficient of Variation 62.4	1.94 ug/mL Geometric Coefficient of Variation 69.3	1.69 ug/mL Geometric Coefficient of Variation 50.2

SECONDARY outcome

Timeframe: C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21

Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.

Plasma samples were collected for PK analysis for belantamab mafodotin ADC.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=38 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=41 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC	6.11 ug/mL Geometric Coefficient of Variation 40.6	8.4 ug/mL Geometric Coefficient of Variation 32.2	5.98 ug/mL Geometric Coefficient of Variation 34.6	7.71 ug/mL Geometric Coefficient of Variation 38.6	6.3 ug/mL Geometric Coefficient of Variation 27.1

SECONDARY outcome

Timeframe: C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21

Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.

Plasma samples were collected to determine the area under the concentration-time curve (AUC) (0-504h) of Belantamab mafodotin ADC.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=38 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=41 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC	3079 micrograms* hour/ millilitre (ug*h/mL) Geometric Coefficient of Variation 40.6	4233 micrograms* hour/ millilitre (ug*h/mL) Geometric Coefficient of Variation 32.2	3013 micrograms* hour/ millilitre (ug*h/mL) Geometric Coefficient of Variation 34.6	3886 micrograms* hour/ millilitre (ug*h/mL) Geometric Coefficient of Variation 38.6	3173 micrograms* hour/ millilitre (ug*h/mL) Geometric Coefficient of Variation 27.1

SECONDARY outcome

Timeframe: C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15

Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.

Plasma samples were collected for PK analysis of Belantamab mafodotin ADC

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=38 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=41 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Half-life (t1/2) of Belantamab Mafodotin ADC	13 Days Geometric Coefficient of Variation 41.3	13 Days Geometric Coefficient of Variation 30.5	12 Days Geometric Coefficient of Variation 32.1	12 Days Geometric Coefficient of Variation 40	12 Days Geometric Coefficient of Variation 34.2

SECONDARY outcome

Timeframe: C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15

Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.

Plasma samples were collected for PK analysis for belantamab mafodotin ADC.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=38 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=41 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Clearance (CL) for Belantamab Mafodotin ADC	0.86 Liter/ days Geometric Coefficient of Variation 59.7	0.8 Liter/ days Geometric Coefficient of Variation 38.3	0.83 Liter/ days Geometric Coefficient of Variation 57.1	0.84 Liter/ days Geometric Coefficient of Variation 47.7	0.74 Liter/ days Geometric Coefficient of Variation 53.3

SECONDARY outcome

Timeframe: C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15

Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.

Plasma samples were collected for PK analysis for belantamab mafodotin ADC.

Outcome measures

Measure	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=38 Participants Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=41 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 Participants Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 Participants Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC	10.0 Liter Geometric Coefficient of Variation 16.1	10.0 Liter Geometric Coefficient of Variation 19.6	9.3 Liter Geometric Coefficient of Variation 26.4	9.4 Liter Geometric Coefficient of Variation 26.9	8.9 Liter Geometric Coefficient of Variation 25.4

Adverse Events

Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)

Serious events: 17 serious events

Other events: 38 other events

Deaths: 23 deaths

Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W

Serious events: 17 serious events

Other events: 36 other events

Deaths: 23 deaths

Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)

Serious events: 21 serious events

Other events: 36 other events

Deaths: 25 deaths

Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W

Serious events: 16 serious events

Other events: 40 other events

Deaths: 21 deaths

Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)

Serious events: 4 serious events

Other events: 16 other events

Deaths: 5 deaths

Serious adverse events

Measure	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=39 participants at risk Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 participants at risk Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 participants at risk Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 participants at risk Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 participants at risk Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Fall	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Subdural haematoma	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Hypercalcaemia	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Hypernatraemia	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Back pain	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Bone lesion	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Muscular weakness	2.6% 1/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Abdominal pain	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Colitis	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Diarrhoea	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Gingival bleeding	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Photophobia	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Hepatobiliary disorders Drug-induced liver injury	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Immune system disorders Cytokine release syndrome	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Investigations Blood creatinine increased	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Investigations Blood lactate dehydrogenase increased	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Nervous system disorders Spinal cord compression	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Nervous system disorders Somnolence	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Psychiatric disorders Confusional state	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Psychiatric disorders Delirium	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Renal and urinary disorders Acute kidney injury	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Renal and urinary disorders Chronic kidney disease	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.6% 1/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Vascular disorders Deep vein thrombosis	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Vascular disorders Pelvic venous thrombosis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Cardiac disorders Cardiac failure	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Respiratory tract infection	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Disease progression	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Pneumonia	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Pneumonia bacterial	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations COVID-19	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Kidney infection	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Respiratory tract infection viral	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Sepsis	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Septic shock	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Streptococcal sepsis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Bacteraemia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations COVID-19 pneumonia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Cellulitis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Coronavirus infection	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Diverticulitis	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Gingivitis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Hepatitis B reactivation	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Herpes zoster	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Infection	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Influenza	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Lower respiratory tract infection	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Metapneumovirus infection	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Pneumonia cytomegaloviral	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Pneumonia parainfluenzae viral	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Pneumonia pneumococcal	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Pulmonary sepsis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Upper respiratory tract infection	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Urinary tract infection	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Vascular device infection	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Blood and lymphatic system disorders Thrombocytopenia	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.0% 4/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Blood and lymphatic system disorders Anaemia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders General physical health deterioration	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Non-cardiac chest pain	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Pain	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Organ failure	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Pyrexia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Systemic inflammatory response syndrome	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.

Other adverse events

Measure	Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) n=39 participants at risk Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.	Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W n=40 participants at risk Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) n=39 participants at risk Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W n=40 participants at risk Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.	Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) n=17 participants at risk Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
Blood and lymphatic system disorders Anaemia	23.1% 9/39 • Number of events 16 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	30.0% 12/40 • Number of events 15 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	30.8% 12/39 • Number of events 13 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	37.5% 15/40 • Number of events 23 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	23.5% 4/17 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Blood and lymphatic system disorders Leukopenia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Blood and lymphatic system disorders Lymphopenia	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Blood and lymphatic system disorders Neutropenia	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	20.0% 8/40 • Number of events 11 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	17.5% 7/40 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	23.5% 4/17 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Blood and lymphatic system disorders Thrombocytopenia	28.2% 11/39 • Number of events 17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	42.5% 17/40 • Number of events 26 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	33.3% 13/39 • Number of events 20 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	25.0% 10/40 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	23.5% 4/17 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Ear and labyrinth disorders Vertigo	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Cataract	12.8% 5/39 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.0% 4/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	17.5% 7/40 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	17.6% 3/17 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Corneal epithelial microcysts	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Corneal erosion	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Dry eye	38.5% 15/39 • Number of events 25 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	30.0% 12/40 • Number of events 17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	30.8% 12/39 • Number of events 33 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	30.0% 12/40 • Number of events 17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	47.1% 8/17 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Eye irritation	28.2% 11/39 • Number of events 20 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	22.5% 9/40 • Number of events 19 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	28.2% 11/39 • Number of events 32 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	27.5% 11/40 • Number of events 21 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	29.4% 5/17 • Number of events 11 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Eye pain	23.1% 9/39 • Number of events 13 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	15.4% 6/39 • Number of events 25 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.0% 4/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	17.6% 3/17 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Eye pruritus	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Eyelid irritation	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Foreign body sensation in eyes	17.9% 7/39 • Number of events 12 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	17.5% 7/40 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	28.2% 11/39 • Number of events 35 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	12.5% 5/40 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	17.6% 3/17 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Lacrimation increased	7.7% 3/39 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.0% 4/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Photophobia	20.5% 8/39 • Number of events 12 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	25.0% 10/40 • Number of events 19 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	25.6% 10/39 • Number of events 19 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	29.4% 5/17 • Number of events 12 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Punctate keratitis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	11.8% 2/17 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Trichiasis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Ulcerative keratitis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	11.8% 2/17 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Eye disorders Vision blurred	41.0% 16/39 • Number of events 36 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	30.0% 12/40 • Number of events 33 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	46.2% 18/39 • Number of events 53 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	27.5% 11/40 • Number of events 19 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	52.9% 9/17 • Number of events 22 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Abdominal pain	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Abdominal pain upper	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Anal incontinence	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Constipation	15.4% 6/39 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	15.4% 6/39 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Diarrhoea	10.3% 4/39 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.3% 4/39 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.0% 4/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Nausea	7.7% 3/39 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	20.5% 8/39 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Stomatitis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Gastrointestinal disorders Vomiting	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Asthenia	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Chest pain	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Fatigue	15.4% 6/39 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	15.0% 6/40 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.3% 4/39 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Pyrexia	10.3% 4/39 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	17.9% 7/39 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	11.8% 2/17 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Sensation of foreign body	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
General disorders Swelling	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Immune system disorders Cytokine release syndrome	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations COVID-19	12.8% 5/39 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Candida infection	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Conjunctivitis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Cystitis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Gastroenteritis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Influenza	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Periorbital cellulitis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Pharyngitis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Pneumonia	7.7% 3/39 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Respiratory tract infection	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Upper respiratory tract infection	20.5% 8/39 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.0% 4/40 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Infections and infestations Urinary tract infection	15.4% 6/39 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Eye injury	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Fall	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Humerus fracture	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Infusion related reaction	12.8% 5/39 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	12.5% 5/40 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	11.8% 2/17 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Injury, poisoning and procedural complications Rib fracture	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Investigations Alanine aminotransferase increased	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Investigations Aspartate aminotransferase increased	10.3% 4/39 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	15.0% 6/40 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.3% 4/39 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	12.5% 5/40 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Investigations Blood alkaline phosphatase increased	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Investigations Blood bilirubin increased	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Investigations Blood creatine phosphokinase increased	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Investigations Blood creatinine increased	2.6% 1/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Investigations Blood lactate dehydrogenase increased	15.4% 6/39 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Investigations Gamma-glutamyltransferase increased	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.0% 4/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Investigations Neutrophil count decreased	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Decreased appetite	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.3% 4/39 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Hypercalcaemia	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.0% 4/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Hyperuricaemia	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	11.8% 2/17 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Hypocalcaemia	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	12.8% 5/39 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.3% 4/39 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.0% 4/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Back pain	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.0% 4/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	12.5% 5/40 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Bone pain	7.7% 3/39 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	12.5% 5/40 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Pain in extremity	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Musculoskeletal and connective tissue disorders Spinal pain	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ocular neoplasm	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Nervous system disorders Dizziness	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Nervous system disorders Headache	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.5% 3/40 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Nervous system disorders Somnolence	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Psychiatric disorders Anxiety	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Psychiatric disorders Insomnia	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Psychiatric disorders Intensive care unit delirium	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Renal and urinary disorders Acute kidney injury	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Renal and urinary disorders Haematuria	10.3% 4/39 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Renal and urinary disorders Proteinuria	5.1% 2/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	11.8% 2/17 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	10.0% 4/40 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Skin and subcutaneous tissue disorders Decubitus ulcer	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Skin and subcutaneous tissue disorders Skin ulcer	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/39 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.9% 1/17 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Vascular disorders Hypertension	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.5% 1/40 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	7.7% 3/39 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	5.0% 2/40 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.
Vascular disorders Hypotension	5.1% 2/39 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	2.6% 1/39 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/40 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.	0.00% 0/17 • All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks. All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.

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