Trial Outcomes & Findings for A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (NCT NCT03819153)

Participant milestones
Measure	Semaglutide Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Overall Study STARTED	1767	1766
Overall Study Full Analysis Set (FAS)	1767	1766
Overall Study COMPLETED	1724	1708
Overall Study NOT COMPLETED	43	58

Reasons for withdrawal
Measure	Semaglutide Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Overall Study Withdrawal by Subject	20	28
Overall Study Lost to Follow-up	23	30

Baseline characteristics by cohort
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Total n=3533 Participants Total of all reporting groups
Age, Continuous	66.6 Years STANDARD_DEVIATION 9.0 • n=5 Participants	66.7 Years STANDARD_DEVIATION 9.0 • n=7 Participants	66.6 Years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	519 Participants n=5 Participants	550 Participants n=7 Participants	1069 Participants n=5 Participants
Sex: Female, Male Male	1248 Participants n=5 Participants	1216 Participants n=7 Participants	2464 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	273 Participants n=5 Participants	283 Participants n=7 Participants	556 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1421 Participants n=5 Participants	1411 Participants n=7 Participants	2832 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	73 Participants n=5 Participants	72 Participants n=7 Participants	145 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	439 Participants n=5 Participants	407 Participants n=7 Participants	846 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	78 Participants n=5 Participants	82 Participants n=7 Participants	160 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	1155 Participants n=5 Participants	1168 Participants n=7 Participants	2323 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	45 Participants n=5 Participants	50 Participants n=7 Participants	95 Participants n=5 Participants
Race/Ethnicity, Customized Race · Not reported	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death	331 Participants	410 Participants

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)	-2.19 (mL/min/1.73 m^2)/year Standard Error 0.1	-3.36 (mL/min/1.73 m^2)/year Standard Error 0.1

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI)	165 Participants	213 Participants

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2	92 Participants	110 Participants

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy	87 Participants	100 Participants

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants From Time of Randomization to Occurrence of Renal Death	5 Participants	5 Participants

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants From Time of Randomization to Occurrence of CV Death	123 Participants	169 Participants

Outcome measures
Measure	Semaglutide n=1735 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1736 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope)	-2.36 mL/min/1.73 m^2 Standard Error 0.1	-3.30 mL/min/1.73 m^2 Standard Error 0.1

Outcome measures
Measure	Semaglutide n=1665 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1663 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Change From Baseline in eGFR (CKD-EPI) at Week 12	-1.07 mL/min/1.73m^2 Standard Deviation 8.16	-1.07 mL/min/1.73m^2 Standard Deviation 7.73

Outcome measures
Measure	Semaglutide n=1425 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1391 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104	-2.1 mL/min/1.73m^2 Standard Deviation 11.4	-5.4 mL/min/1.73m^2 Standard Deviation 9.7

Outcome measures
Measure	Semaglutide n=1454 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1423 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline	0.60 Ratio Geometric Coefficient of Variation 224.09	0.89 Ratio Geometric Coefficient of Variation 211.70

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV Death	212 Participants	254 Participants

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants From Time of Randomization to Time to Occurrence of All-cause Death	227 Participants	279 Participants

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Myocardial Infarction	52 Participants	64 Participants

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Stroke	63 Participants	51 Participants

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants From Time of Randomization to Time to First Occurrence of Major Adverse Limb Events (MALE): Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization	16 Participants	28 Participants

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization Acute limb ischaemia hospitalization	1 Participants	3 Participants
Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization Chronic limb ischaemia hospitalization	16 Participants	25 Participants

Outcome measures
Measure	Semaglutide n=1502 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1468 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Change From Baseline in Body Weight at Week 104	-5.54 Kilograms Standard Deviation 6.57	-1.43 Kilograms Standard Deviation 6.33

Outcome measures
Measure	Semaglutide n=1448 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1427 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 104	-0.86 Percentage of HbA1c Standard Deviation 1.35	-0.04 Percentage of HbA1c Standard Deviation 1.29

Outcome measures
Measure	Semaglutide n=1511 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1472 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Change From Baseline in Systolic Blood Pressure at Week 104	-3.9 Millimeters of mercury Standard Deviation 17.6	-1.4 Millimeters of mercury Standard Deviation 18.3

Outcome measures
Measure	Semaglutide n=1511 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1472 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Change From Baseline in Diastolic Blood Pressure at Week 104	-0.4 millimeters of mercury Standard Deviation 9.6	-0.8 millimeters of mercury Standard Deviation 10.4

Outcome measures
Measure	Semaglutide n=1767 Participants Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 Participants Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Number of Severe Hypoglycaemic Episodes	37 Episodes	37 Episodes

Gastrointestinal disorders

Abdominal distension

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Abdominal hernia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Abdominal hernia obstructive

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Abdominal hernia repair

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Abdominal incarcerated hernia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Abdominal pain

0.23%

4/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.34%

6/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Abdominal pain lower

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Abdominal pain upper

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Abdominal wall abscess

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Abnormal behaviour

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Abnormal loss of weight

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Abnormal uterine bleeding

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Abscess limb

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Accelerated hypertension

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Acute coronary syndrome

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Acute kidney injury

7.0%

124/1767 • Number of events 165 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

7.0%

123/1766 • Number of events 143 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Acute left ventricular failure

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.34%

6/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acute myeloid leukaemia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Acute myocardial infarction

2.8%

49/1767 • Number of events 52 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

3.8%

67/1766 • Number of events 81 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Acute pulmonary oedema

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.68%

12/1766 • Number of events 13 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure

1.7%

30/1767 • Number of events 31 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.8%

32/1766 • Number of events 37 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Acute sinusitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma gastric

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma of colon

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma pancreas

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenoma benign

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Adjustment disorder

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Adnexa uteri mass

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Endocrine disorders

Adrenal insufficiency

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adrenal neoplasm

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Alanine aminotransferase increased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Albuminuria

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Alcohol poisoning

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Altered state of consciousness

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Immune system disorders

Amyloidosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Anaemia

1.0%

18/1767 • Number of events 25 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.4%

24/1766 • Number of events 28 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Anaemia postoperative

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Anal abscess

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Anal cancer

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Anal fissure haemorrhage

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Anal ulcer haemorrhage

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Immune system disorders

Anaphylactic reaction

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Angina pectoris

0.74%

13/1767 • Number of events 16 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.91%

16/1766 • Number of events 16 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Angina unstable

0.68%

12/1767 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.2%

22/1766 • Number of events 24 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Angioedema

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Angiolipoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Angiopathy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Ankle fracture

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Ankylosing spondylitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Antisynthetase syndrome

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Anuria

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Aortic aneurysm

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Aortic aneurysm rupture

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Aortic dilatation

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Aortic dissection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Aortic stenosis

0.40%

7/1767 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Aortic thrombosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Aortic valve disease mixed

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Aortic valve incompetence

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Aortic valve stenosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Aortoenteric fistula

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Appendicitis

0.45%

8/1767 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Appendicitis perforated

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Arrhythmia

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Arterial disorder

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Arteriosclerosis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Arteriosclerosis coronary artery

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Arteriovenous fistula occlusion

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Arteriovenous fistula operation

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Arthralgia

0.06%

1/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Arthritis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Arthritis bacterial

0.23%

4/1767 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Arthritis reactive

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Ascites

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Aspartate aminotransferase increased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Aspiration

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Asthenia

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Asthma

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Ataxia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Atrial fibrillation

1.8%

31/1767 • Number of events 35 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.2%

22/1766 • Number of events 31 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Atrial flutter

0.62%

11/1767 • Number of events 14 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 10 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Congenital, familial and genetic disorders

Atrial septal defect

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Atrial tachycardia

0.11%

2/1767 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Atrial thrombosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Atrioventricular block

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Atrioventricular block complete

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Atrioventricular block first degree

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Atrioventricular block second degree

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Atypical pneumonia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Autonomic nervous system imbalance

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Autonomic neuropathy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Azotaemia

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

B-cell lymphoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

B-cell small lymphocytic lymphoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Back disorder

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Back pain

0.34%

6/1767 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Bacteraemia

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Bacterial infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Bacterial prostatitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Bacterial sepsis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Balanoposthitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal cell carcinoma

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Basal ganglia infarction

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Behcet's syndrome

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Bell's palsy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign duodenal neoplasm

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign neoplasm of eyelid

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign neoplasm of thyroid gland

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Benign prostatic hyperplasia

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Beta haemolytic streptococcal infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bile duct cancer

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Bile duct stone

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Biliary tract infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Bipolar disorder

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder neoplasm

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder squamous cell carcinoma stage unspecified

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder transitional cell carcinoma

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Blepharitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Blindness unilateral

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Blister

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Blood bilirubin increased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Blood creatinine increased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Blood folate decreased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Blood glucose abnormal

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Blood glucose fluctuation

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Blood loss anaemia

0.11%

2/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Blood potassium increased

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Blood pressure fluctuation

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Blood pressure inadequately controlled

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Bone abscess

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Bradyarrhythmia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Bradycardia

0.34%

6/1767 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.34%

6/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Brain compression

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Brain contusion

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Brain injury

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Brain natriuretic peptide increased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Brain oedema

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Brain stem infarction

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Brain stem stroke

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Bronchitis

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Bursitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Bursitis infective

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

COVID-19

3.3%

58/1767 • Number of events 59 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

4.2%

74/1766 • Number of events 74 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

COVID-19 pneumonia

3.8%

68/1767 • Number of events 68 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

4.7%

83/1766 • Number of events 83 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Calculus urinary

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cancer pain

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Candida infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Candida sepsis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Carbuncle

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Carcinoid tumour pulmonary

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiac aneurysm

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiac arrest

0.91%

16/1767 • Number of events 18 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.79%

14/1766 • Number of events 14 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiac asthma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Cardiac death

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiac failure

2.7%

48/1767 • Number of events 63 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

3.7%

66/1766 • Number of events 89 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiac failure acute

1.5%

27/1767 • Number of events 30 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.5%

26/1766 • Number of events 32 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiac failure chronic

1.0%

18/1767 • Number of events 19 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.0%

18/1766 • Number of events 19 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiac failure congestive

1.9%

33/1767 • Number of events 40 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

2.8%

49/1766 • Number of events 56 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiac hypertrophy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Cardiac pacemaker removal

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Cardiac pacemaker replacement

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiac tamponade

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiac valve disease

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiac ventricular thrombosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardio-respiratory arrest

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiogenic shock

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.34%

6/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiomegaly

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiomyopathy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiopulmonary failure

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiorenal syndrome

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiovascular disorder

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cardiovascular insufficiency

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Carotid arteriosclerosis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Carotid artery occlusion

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Carotid artery stenosis

0.40%

7/1767 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Carpal tunnel syndrome

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Cataract

1.2%

22/1767 • Number of events 27 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.74%

13/1766 • Number of events 16 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Cataract operation

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Cellulitis

0.68%

12/1767 • Number of events 17 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.5%

26/1766 • Number of events 31 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Cellulitis staphylococcal

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Central cord syndrome

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cerebellar infarction

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cerebellar stroke

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cerebral artery occlusion

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cerebral atrophy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cerebral cyst

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cerebral haemorrhage

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cerebral infarction

0.62%

11/1767 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cerebral ischaemia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cerebrovascular accident

0.85%

15/1767 • Number of events 15 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.74%

13/1766 • Number of events 13 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cerebrovascular disorder

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Cervical spinal stenosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Cervical vertebral fracture

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cervicobrachial syndrome

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Chagas' cardiomyopathy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Change of bowel habit

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Chest discomfort

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Chest pain

0.51%

9/1767 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Choking

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cholangiocarcinoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Cholangitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Cholangitis acute

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Cholangitis infective

0.06%

1/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Cholecystectomy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Cholecystitis

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Cholecystitis acute

0.68%

12/1767 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.85%

15/1766 • Number of events 16 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Cholecystitis chronic

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Cholelithiasis

0.74%

13/1767 • Number of events 13 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.68%

12/1766 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Cholestasis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Cholestatic liver injury

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Chorioretinitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chromophobe renal cell carcinoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Chronic hepatic failure

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Chronic kidney disease

2.4%

42/1767 • Number of events 48 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

2.1%

37/1766 • Number of events 37 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Chronic left ventricular failure

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chronic leukaemia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chronic lymphocytic leukaemia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease

0.34%

6/1767 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.51%

9/1766 • Number of events 10 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Chronic respiratory disease

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Circulatory collapse

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Claudication of jaw muscles

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Clavicle fracture

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Clear cell renal cell carcinoma

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Clostridium colitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Clostridium difficile colitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Clostridium difficile infection

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Coagulopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cognitive disorder

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Colitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Colitis ischaemic

0.17%

3/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer metastatic

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer stage IV

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon neoplasm

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colorectal adenoma

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colorectal cancer

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Colpocele

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Coma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Complicated appendicitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Complication associated with device

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Concussion

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Confusional state

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Constipation

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Immune system disorders

Contrast media allergy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Contrast media toxicity

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Contusion

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Cor pulmonale

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Coronary artery bypass

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Coronary artery disease

1.8%

31/1767 • Number of events 37 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.6%

28/1766 • Number of events 29 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Coronary artery occlusion

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Coronary artery restenosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Coronary artery stenosis

0.45%

8/1767 • Number of events 11 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.57%

10/1766 • Number of events 11 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Coronary artery thrombosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Coronary vascular graft occlusion

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Coronary vascular graft stenosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Coronavirus infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Coronavirus pneumonia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Costochondritis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Cough

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Cranial nerve paralysis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Craniocerebral injury

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Craniofacial fracture

0.17%

3/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Cystitis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Cystitis haemorrhagic

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Death

1.2%

21/1767 • Number of events 21 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.7%

30/1766 • Number of events 30 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Decreased appetite

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Decubitus ulcer

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Deep vein thrombosis

0.34%

6/1767 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Dehydration

0.57%

10/1767 • Number of events 13 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.57%

10/1766 • Number of events 10 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Delirium

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Dementia

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Dengue fever

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Depression

0.06%

1/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Dermal cyst

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Product Issues

Device malfunction

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Product Issues

Device occlusion

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Device related infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Device related sepsis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Device related thrombosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Diabetes mellitus

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Diabetes mellitus inadequate control

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Diabetic autonomic neuropathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Diabetic complication renal

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Diabetic end stage renal disease

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Diabetic foot

0.62%

11/1767 • Number of events 14 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.68%

12/1766 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Diabetic foot infection

0.34%

6/1767 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Diabetic gangrene

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Diabetic ketoacidosis

0.57%

10/1767 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Diabetic macroangiopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Diabetic metabolic decompensation

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.34%

6/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Diabetic nephropathy

0.51%

9/1767 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Diabetic neuropathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Diabetic retinal oedema

0.17%

3/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Diabetic retinopathy

0.68%

12/1767 • Number of events 15 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.51%

9/1766 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Diabetic vascular disorder

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Diarrhoea

0.57%

10/1767 • Number of events 11 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Congenital, familial and genetic disorders

Dilatation intrahepatic duct congenital

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Disseminated intravascular coagulation

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Diverticulitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Diverticulitis intestinal haemorrhagic

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Diverticulum

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Diverticulum intestinal

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Dizziness

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Dizziness postural

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Drug reaction with eosinophilia and systemic symptoms

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Drug-induced liver injury

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Dry gangrene

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ductal adenocarcinoma of pancreas

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Duodenal ulcer

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Duodenal ulcer haemorrhage

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Duodenal ulcer perforation

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Dysphagia

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Dyspnoea

0.51%

9/1767 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.62%

11/1766 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Dyspnoea exertional

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Ear and labyrinth disorders

Ear pain

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Eczema

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Electrolyte imbalance

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Embolic stroke

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Embolism arterial

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Emphysematous cystitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Encephalomalacia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Encephalopathy

0.40%

7/1767 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

End stage renal disease

1.8%

31/1767 • Number of events 33 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

2.0%

36/1766 • Number of events 37 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Endocarditis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Endocarditis bacterial

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Endometrial adenocarcinoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Endometrial cancer

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Endophthalmitis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Endotracheal intubation complication

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Enterocolitis bacterial

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Enterocolitis viral

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Epilepsy

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Epiretinal membrane

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Epistaxis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Erosive oesophagitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Erysipelas

0.40%

7/1767 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Escherichia bacteraemia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Escherichia infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Escherichia sepsis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Escherichia urinary tract infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Exfoliation glaucoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Exposure to toxic agent

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Extranodal marginal zone B-cell lymphoma (MALT type)

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Extremity necrosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Eye infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Eyelid ptosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Facial paralysis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Fall

0.96%

17/1767 • Number of events 18 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.1%

20/1766 • Number of events 21 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Fatigue

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Febrile infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Femoral neck fracture

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Femur fracture

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Fibula fracture

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Flatback syndrome

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Fluid retention

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Food poisoning

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Foot deformity

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Fournier's gangrene

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Fungal oesophagitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Fungal peritonitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Gait disturbance

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Gallbladder empyema

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Gallbladder enlargement

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gallbladder neoplasm

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Gangrene

0.57%

10/1767 • Number of events 14 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.62%

11/1766 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric cancer

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric cancer stage III

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Gastric haemorrhage

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Gastric polyps

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Gastric ulcer

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Gastric ulcer haemorrhage

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Gastric ulcer perforation

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Gastritis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Gastritis haemorrhagic

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Gastroenteritis

0.45%

8/1767 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.34%

6/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Gastroenteritis bacterial

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Gastroenteritis clostridial

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Gastroenteritis viral

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Gastrointestinal haemorrhage

0.51%

9/1767 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.57%

10/1766 • Number of events 10 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Gastrointestinal polyp haemorrhage

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastrointestinal stromal tumour

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastrointestinal tract adenoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Gastrooesophageal reflux disease

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

General physical health deterioration

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

General symptom

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Generalised oedema

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Generalised tonic-clonic seizure

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Gingival bleeding

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Glaucoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Glioblastoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Glomerular filtration rate abnormal

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Glomerular filtration rate decreased

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Glomerulonephritis proliferative

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Endocrine disorders

Goitre

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Gout

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Gouty arthritis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Gouty tophus

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Granulomatosis with polyangiitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Guillain-Barre syndrome

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Haemarthrosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Haematemesis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Haematochezia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Haematoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Haematoma infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Haematuria

0.11%

2/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Haemobilia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Haemodialysis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Haemodialysis complication

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Haemodynamic instability

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Haemoglobinuria

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Haemophilus infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Haemoptysis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Haemorrhage intracranial

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Haemorrhagic stroke

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Haemorrhagic transformation stroke

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Haemorrhoids

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Haemothorax

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Hallucination

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Head injury

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Headache

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Hemiparesis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic cancer

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Hepatic cirrhosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Hepatic cyst

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Hepatic encephalopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Hepatic enzyme increased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Hepatic failure

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Hepatic mass

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Hepatitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Hepatitis B

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Hepatitis cholestatic

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatocellular carcinoma

0.34%

6/1767 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Hepatorenal syndrome

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Hernia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Hernial eventration

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Herpes virus infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Herpes zoster

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Herpes zoster infection neurological

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Hiatus hernia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Hip arthroplasty

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Hip fracture

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Hip surgery

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Humerus fracture

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Congenital, familial and genetic disorders

Hydrocele

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Hydrocephalus

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Hydrocholecystis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Hydronephrosis

0.11%

2/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Hydrothorax

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hyperammonaemia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hypercalcaemia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Hypercapnia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hyperglycaemia

0.45%

8/1767 • Number of events 11 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.62%

11/1766 • Number of events 15 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hyperglycaemic hyperosmolar nonketotic syndrome

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hyperkalaemia

0.85%

15/1767 • Number of events 18 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.3%

23/1766 • Number of events 24 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Endocrine disorders

Hyperparathyroidism primary

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Hyperplasia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Hyperpyrexia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Immune system disorders

Hypersensitivity

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Hypertension

0.51%

9/1767 • Number of events 13 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.96%

17/1766 • Number of events 19 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Hypertensive crisis

0.40%

7/1767 • Number of events 10 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Hypertensive emergency

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Hypertensive heart disease

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Hypertensive nephropathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Hypertensive urgency

0.45%

8/1767 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.34%

6/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hypertriglyceridaemia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Congenital, familial and genetic disorders

Hypertrophic cardiomyopathy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hyperuricaemia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hypervolaemia

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.85%

15/1766 • Number of events 19 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Hypoaesthesia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Hypoaesthesia oral

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hypoalbuminaemia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hypocalcaemia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Hypochromic anaemia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hypoglycaemia

1.2%

22/1767 • Number of events 23 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.4%

24/1766 • Number of events 27 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Hypoglycaemic coma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Hypoglycaemic encephalopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Hypoglycaemic seizure

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Hypoglycaemic unconsciousness

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hypokalaemia

0.23%

4/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hypomagnesaemia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hyponatraemia

0.40%

7/1767 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hypophosphataemia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Hypotension

0.79%

14/1767 • Number of events 16 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Hypothermia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hypovitaminosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Hypovolaemia

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Hypovolaemic shock

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Hypoxia

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

IIIrd nerve paralysis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Ileus

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Ileus paralytic

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Iliac artery occlusion

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Iliac artery stenosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Impaired gastric emptying

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Impaired healing

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Incarcerated inguinal hernia

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Incarcerated umbilical hernia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Incisional hernia

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Infected fistula

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Infected skin ulcer

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Infectious pleural effusion

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Infective aortitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Infective exacerbation of chronic obstructive airways disease

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Inflammation

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Influenza

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Inguinal hernia

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Inguinal hernia repair

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Insomnia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Intentional overdose

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Intercapillary glomerulosclerosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Intermenstrual bleeding

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Intermittent claudication

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Intervertebral disc degeneration

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Intervertebral disc disorder

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Intervertebral disc displacement

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Intervertebral disc protrusion

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Intervertebral discitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Intestinal ischaemia

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Intestinal mass

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Intestinal obstruction

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Intestinal perforation

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Intestinal polyp

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Intra-abdominal haematoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Intracranial aneurysm

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intraductal papillary mucinous neoplasm

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Intraventricular haemorrhage

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Invasive breast carcinoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Invasive lobular breast carcinoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Iron deficiency anaemia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Irritable bowel syndrome

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Ischaemia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Ischaemic cardiomyopathy

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Ischaemic cerebral infarction

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Ischaemic stroke

1.3%

23/1767 • Number of events 23 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.9%

34/1766 • Number of events 36 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Joint dislocation

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Joint injury

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Keratinising squamous cell carcinoma of nasopharynx

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Keratitis bacterial

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Ketoacidosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Klebsiella infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Klebsiella urinary tract infection

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Knee arthroplasty

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Knee operation

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Laboratory test abnormal

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Lactic acidosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Lacunar infarction

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Lacunar stroke

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Large intestinal obstruction

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Large intestine infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Large intestine perforation

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Large intestine polyp

0.34%

6/1767 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.45%

8/1766 • Number of events 10 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal cancer stage 0

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal squamous cell carcinoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Left ventricular dysfunction

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Left ventricular failure

0.28%

5/1767 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.62%

11/1766 • Number of events 11 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Leg amputation

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Leriche syndrome

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Leukocytosis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Leukocyturia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Ligament sprain

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Light chain disease

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Limb injury

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Linear IgA disease

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Liver abscess

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Liver disorder

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Liver function test increased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Liver injury

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Localised infection

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Localised oedema

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Loss of consciousness

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Lower gastrointestinal haemorrhage

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Lower limb fracture

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Lower respiratory tract infection

0.11%

2/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Lumbar radiculopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Lumbar spinal stenosis

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Lumbar vertebral fracture

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.34%

6/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma stage 0

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma stage IV

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung cancer metastatic

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Lung disorder

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm malignant

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Lymphadenopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Lymphoedema

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lymphoplasmacytoid lymphoma/immunocytoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Macular hole

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Macular oedema

0.11%

2/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Maculopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Malaise

0.06%

1/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant melanoma

0.06%

1/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant melanoma in situ

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant neoplasm of unknown primary site

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Mallory-Weiss syndrome

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Malnutrition

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Mechanical ileus

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Meningioma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Meningoencephalitis herpetic

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Meniscus injury

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Mental status changes

0.11%

2/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Metabolic acidosis

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Metabolic encephalopathy

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to bone

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to liver

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to lung

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to pancreas

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to peritoneum

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic gastric cancer

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic malignant melanoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic renal cell carcinoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Microcytic anaemia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Middle cerebral artery stroke

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Migraine

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Mitral valve incompetence

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Mitral valve stenosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Mixed hepatocellular cholangiocarcinoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Monoclonal gammopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Monoplegia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Mucinous breast carcinoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Mucosal hypertrophy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Multiple injuries

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Multiple organ dysfunction syndrome

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.51%

9/1766 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Multiple sclerosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Muscle strain

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Muscular weakness

0.17%

3/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myelodysplastic syndrome

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myelodysplastic syndrome with single lineage dysplasia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Myelopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myeloproliferative neoplasm

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Myocardial fibrosis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Myocardial infarction

0.85%

15/1767 • Number of events 15 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.85%

15/1766 • Number of events 15 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Myocardial ischaemia

0.57%

10/1767 • Number of events 10 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Myocarditis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Nasal polyps

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Nasopharyngeal cancer

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Nausea

0.34%

6/1767 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Necrotising fasciitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Necrotising oesophagitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm prostate

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Nephrogenic anaemia

0.17%

3/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Nephrolithiasis

0.40%

7/1767 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Nephropathy

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Nephropathy toxic

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Nephrotic syndrome

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine carcinoma metastatic

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine tumour of the lung

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine tumour of the lung metastatic

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Neurogenic shock

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Neuropathic arthropathy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Neuropathy peripheral

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Neutropenia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Nodal arrhythmia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Nodal rhythm

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Non-cardiac chest pain

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.45%

8/1766 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-small cell lung cancer stage II

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-small cell lung cancer stage IV

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Normocytic anaemia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Nosocomial infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Obstructive pancreatitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Obstructive sleep apnoea syndrome

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Ocular ischaemic syndrome

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Oedema

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Oedema peripheral

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Oesophageal fistula

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Oesophageal food impaction

0.06%

1/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Oesophageal stenosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Oesophageal varices haemorrhage

0.06%

1/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Oliguria

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Orchitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Orthopnoea

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Orthostatic hypotension

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Osteitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Osteoarthritis

0.45%

8/1767 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.51%

9/1766 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Osteomyelitis

0.51%

9/1767 • Number of events 11 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.74%

13/1766 • Number of events 15 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Osteomyelitis acute

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Osteomyelitis bacterial

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Osteoporosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Otitis media

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Ovarian cyst

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Overdose

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Pacing induced cardiomyopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Pain

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Palpitations

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma metastatic

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Pancreatic failure

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic neoplasm

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic neuroendocrine tumour

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Pancreatic pseudocyst

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Pancreatitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Pancreatitis acute

0.34%

6/1767 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Pancreatitis chronic

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Pancreatitis necrotising

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Pancytopenia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Panic attack

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Papillary renal cell carcinoma

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Papillary thyroid cancer

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Parainfluenzae virus infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Paranoia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Parapharyngeal space infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Parathyroid tumour benign

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Parkinson's disease

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Partial seizures

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Patella fracture

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Pelvic fracture

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Pemphigoid

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Penile abscess

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Percutaneous coronary intervention

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Periarthritis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Pericardial calcification

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Pericardial effusion

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Pericarditis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Pericarditis uraemic

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Perinephric abscess

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Periorbital cellulitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Peripheral arterial occlusive disease

0.57%

10/1767 • Number of events 11 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.1%

19/1766 • Number of events 29 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Peripheral artery aneurysm

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Peripheral artery occlusion

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Peripheral artery stenosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Peripheral artery thrombosis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Peripheral ischaemia

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.51%

9/1766 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Peripheral swelling

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Peripheral vascular disorder

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Peripheral vascular haematoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Peritoneocutaneous fistula

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Peritonitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Congenital, familial and genetic disorders

Phimosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Plasma cell myeloma

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Pleural effusion

0.51%

9/1767 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pleurisy viral

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pneumocystis jirovecii pneumonia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pneumonia

3.7%

66/1767 • Number of events 70 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

4.2%

75/1766 • Number of events 87 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pneumonia aspiration

0.34%

6/1767 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pneumonia bacterial

0.17%

3/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.62%

11/1766 • Number of events 11 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pneumonia influenzal

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pneumonia klebsiella

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pneumonia legionella

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pneumonia pseudomonal

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pneumonia staphylococcal

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pneumonia viral

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Pneumonitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Pneumothorax

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Poisoning

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Polycythaemia vera

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Polymyalgia rheumatica

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Hepatobiliary disorders

Post cholecystectomy syndrome

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Post herpetic neuralgia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Post procedural haemorrhage

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Post procedural infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Post-acute COVID-19 syndrome

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Post-traumatic stress disorder

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Postoperative ileus

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Postoperative renal failure

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Postoperative wound infection

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Ear and labyrinth disorders

Presbyacusis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Presyncope

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Immune system disorders

Primary amyloidosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Procedural intestinal perforation

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Procedural pneumothorax

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Procedural shock

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Procedural vomiting

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Proctitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer

0.51%

9/1767 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.34%

6/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

SARS-CoV-2 test positive

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer metastatic

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer recurrent

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer stage II

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostatic adenoma

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Prostatitis

0.11%

2/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Product Issues

Prosthetic cardiac valve malfunction

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Proteinuria

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pseudoaneurysm infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Congenital, familial and genetic disorders

Pseudohypoaldosteronism

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Psoas abscess

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Psoriatic arthropathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Pulmonary congestion

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism

0.34%

6/1767 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.62%

11/1766 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Pulmonary fibrosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Pulmonary hypertension

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Pulmonary infarction

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Pulmonary oedema

0.51%

9/1767 • Number of events 10 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.79%

14/1766 • Number of events 14 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Pulmonary pain

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pulmonary tuberculosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Pulmonary valve incompetence

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Pulmonary valve stenosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Pulse abnormal

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Purpura

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pyelonephritis

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pyelonephritis acute

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Pyelonephritis chronic

0.06%

1/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Pyrexia

0.17%

3/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Radiculopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Radius fracture

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal adenocarcinoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal cancer

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Rectal haemorrhage

0.06%

1/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal neoplasm

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Rectal ulcer

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectosigmoid cancer

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Recurrent cancer

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Renal abscess

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Renal artery stenosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cancer

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cancer metastatic

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cell carcinoma

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cell carcinoma stage I

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Renal colic

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Renal cyst

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Renal cyst ruptured

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Renal disorder

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Renal failure

0.45%

8/1767 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.96%

17/1766 • Number of events 17 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Renal impairment

0.51%

9/1767 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.0%

18/1766 • Number of events 21 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Renal injury

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Renal mass

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal neoplasm

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal oncocytoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Renal transplant

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Renal tubular acidosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Renal tubular necrosis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Respiratory acidosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Respiratory arrest

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Respiratory distress

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Respiratory failure

1.1%

20/1767 • Number of events 20 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.62%

11/1766 • Number of events 12 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Respiratory syncytial virus infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Respiratory tract infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Respiratory tract infection viral

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Retinal artery occlusion

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Retinal detachment

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Retinal haemorrhage

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Retinal vein occlusion

0.06%

1/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Retinal vein thrombosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Retinopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Retinopathy proliferative

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Retroperitoneal haematoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Rhabdomyolysis

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Rib fracture

0.40%

7/1767 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.23%

4/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Right ventricular failure

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Road traffic accident

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Rotator cuff syndrome

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Ruptured cerebral aneurysm

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

SARS-CoV-2 sepsis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Sciatica

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Scrotal abscess

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Seizure

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Seizure like phenomena

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Sepsis

0.96%

17/1767 • Number of events 20 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.3%

23/1766 • Number of events 24 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Septic encephalopathy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Septic pulmonary embolism

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Septic shock

0.45%

8/1767 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.79%

14/1766 • Number of events 14 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Serous cystadenocarcinoma ovary

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Serratia infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Severe acute respiratory syndrome

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Shock

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Shock haemorrhagic

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Shoulder fracture

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Shunt infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Shunt malfunction

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Shunt occlusion

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Sinus bradycardia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Sinus node dysfunction

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Sinus tachycardia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Sinusitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Skin infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Skin laceration

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Skin lesion removal

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Skin necrosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Skin ulcer

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.40%

7/1766 • Number of events 13 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Skull fracture

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small cell lung cancer

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small cell lung cancer metastatic

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Small intestinal obstruction

0.17%

3/1767 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small intestine neuroendocrine tumour

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Small intestine polyp

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Soft tissue infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Soft tissue injury

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Soft tissue sarcoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Spinal column injury

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Spinal compression fracture

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Spinal cord compression

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Spinal cord injury

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Spinal decompression

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Spinal epidural haematoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Spinal fracture

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Spinal fusion surgery

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Spinal osteoarthritis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Spinal pain

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Spinal stenosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Splenic infarction

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Spondyloarthropathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Spondylolisthesis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Spontaneous bacterial peritonitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of lung

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of skin

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of the hypopharynx

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Staphylococcal bacteraemia

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Staphylococcal infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Staphylococcal sepsis

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Stasis dermatitis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Status epilepticus

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Stent-graft endoleak

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Skin and subcutaneous tissue disorders

Stevens-Johnson syndrome

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Strangulated umbilical hernia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Streptococcal sepsis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Subarachnoid haemorrhage

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Subcapsular renal haematoma

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Subcutaneous abscess

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Subcutaneous haematoma

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Subdural haematoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Subileus

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Sudden cardiac death

0.23%

4/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Sudden death

0.28%

5/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.57%

10/1766 • Number of events 10 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Psychiatric disorders

Suicide attempt

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Superficial vein thrombosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Superinfection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Supraventricular tachycardia

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Suspected COVID-19

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Syncope

0.79%

14/1767 • Number of events 16 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.51%

9/1766 • Number of events 9 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Synovial cyst

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Systemic inflammatory response syndrome

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Systolic dysfunction

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Systolic hypertension

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Tachyarrhythmia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Tendon injury

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Tendon pain

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Tension headache

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Testicular pain

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Tethered cord syndrome

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Thalamic infarction

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Thalamic stroke

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Thalamus haemorrhage

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Thermal burn

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Thoracic vertebral fracture

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Thrombocytopenia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Blood and lymphatic system disorders

Thrombocytosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Thrombophlebitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Thrombosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Tibia fracture

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Tidal volume decreased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Toe amputation

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Toxic encephalopathy

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Toxicity to various agents

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Tractional retinal detachment

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Surgical and medical procedures

Transcatheter aortic valve implantation

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Transient ischaemic attack

0.85%

15/1767 • Number of events 15 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.74%

13/1766 • Number of events 14 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Transitional cell cancer of the renal pelvis and ureter

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Transitional cell carcinoma

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 6 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Traumatic intracranial haemorrhage

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Traumatic ulcer

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Tremor

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Tricuspid valve incompetence

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Troponin T increased

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Troponin increased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Tubulointerstitial nephritis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Type 2 diabetes mellitus

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Ulcer haemorrhage

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Ulcerative gastritis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Ulcerative keratitis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Ulna fracture

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Umbilical hernia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Umbilical hernia, obstructive

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Upper gastrointestinal haemorrhage

0.23%

4/1767 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Upper motor neurone lesion

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Upper respiratory tract infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Uraemic encephalopathy

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Uraemic gastropathy

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Ureterolithiasis

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Urethral stenosis

0.17%

3/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Urinary retention

0.40%

7/1767 • Number of events 7 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Urinary tract candidiasis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Urinary tract infection

1.3%

23/1767 • Number of events 27 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

1.5%

27/1766 • Number of events 30 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Urinary tract infection bacterial

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Urinary tract infection pseudomonal

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Renal and urinary disorders

Urinary tract obstruction

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Urosepsis

0.17%

3/1767 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Uterine leiomyoma

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Uterine polyp

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Uterine prolapse

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Uterovaginal prolapse

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Reproductive system and breast disorders

Vaginal haemorrhage

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Vascular dementia

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Vascular device infection

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Vascular encephalopathy

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Vascular graft stenosis

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Vascular occlusion

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Vascular pseudoaneurysm

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Vascular shunt

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

General disorders

Vascular stent occlusion

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Vasculitis necrotising

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Respiratory, thoracic and mediastinal disorders

Vasomotor rhinitis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Vascular disorders

Venous thrombosis limb

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Ventricular arrhythmia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Ventricular extrasystoles

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Ventricular fibrillation

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.17%

3/1766 • Number of events 3 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Ventricular tachyarrhythmia

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Cardiac disorders

Ventricular tachycardia

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Musculoskeletal and connective tissue disorders

Vertebral foraminal stenosis

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Vertebrobasilar stroke

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Ear and labyrinth disorders

Vertigo

0.45%

8/1767 • Number of events 8 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Nervous system disorders

Vertigo CNS origin

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Ear and labyrinth disorders

Vertigo positional

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Viral infection

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.11%

2/1766 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Viral upper respiratory tract infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Vision blurred

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Metabolism and nutrition disorders

Vitamin D deficiency

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Eye disorders

Vitreous haemorrhage

0.17%

3/1767 • Number of events 4 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Gastrointestinal disorders

Vomiting

0.62%

11/1767 • Number of events 11 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.28%

5/1766 • Number of events 5 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Vulval abscess

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Vulval cancer stage 0

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

Weight increased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Investigations

White blood cell count increased

0.00%

0/1767 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Wound evisceration

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Infections and infestations

Wound infection

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Wound necrosis

0.11%

2/1767 • Number of events 2 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.00%

0/1766 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Injury, poisoning and procedural complications

Wrist fracture

0.06%

1/1767 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

0.06%

1/1766 • Number of events 1 • From Week 0 up to Week 238

The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Measure	Semaglutide n=1767 participants at risk Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	Placebo n=1766 participants at risk Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
Infections and infestations COVID-19	12.5% 221/1767 • Number of events 238 • From Week 0 up to Week 238 The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.	13.9% 246/1766 • Number of events 260 • From Week 0 up to Week 238 The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.
Eye disorders Diabetic retinopathy	19.2% 339/1767 • Number of events 394 • From Week 0 up to Week 238 The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.	18.4% 325/1766 • Number of events 381 • From Week 0 up to Week 238 The safety evaluation was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. Details on the approach followed for collecting the AEs is mentioned in the section 9.3 of protocol.

Trial Outcomes & Findings for A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (NCT NCT03819153)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

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Adverse Events

Semaglutide

Placebo

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Additional Information

Clinical Reporting Office (2834)

Results disclosure agreements