Trial Outcomes & Findings for Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis (NCT NCT02092467)

NCT ID: NCT02092467

Last Updated: 2021-08-17

Results Overview

Incidence rate (number of participants with event per 100 participant year \[PY\]) was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Malignancy events, excluding NMSC were adjudicated by a steering committee. The risk period (RP) was the last contact date. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 4372 participants
• Primary outcome timeframe: Baseline up to last contact date (maximum up to 72 months)
• Results posted on: 2021-08-17

Participant Flow

Study started from 14 March 2014 and completed on 22 July 2020.

Participant milestones

Measure	Tofacitinib 5 mg BID Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Overall Study STARTED	1457	1457	1458
Overall Study Treated	1455	1456	1451
Overall Study COMPLETED	1053	998	1060
Overall Study NOT COMPLETED	404	459	398

Reasons for withdrawal

Measure	Tofacitinib 5 mg BID Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Overall Study Death	49	66	38
Overall Study Lost to Follow-up	38	35	40
Overall Study Global Deterioration of Health Status	1	0	0
Overall Study Other	32	30	24
Overall Study Withdrawal by Subject	282	327	289
Overall Study Randomized but not treated	2	1	7

Baseline Characteristics

Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	TNFi n=1451 Participants In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Total n=4362 Participants Total of all reporting groups
Age, Continuous	60.75 years STANDARD_DEVIATION 6.80 • n=5 Participants	61.40 years STANDARD_DEVIATION 7.07 • n=7 Participants	61.30 years STANDARD_DEVIATION 7.47 • n=5 Participants	61.15 years STANDARD_DEVIATION 7.12 • n=4 Participants
Sex: Female, Male Female	1169 Participants n=5 Participants	1124 Participants n=7 Participants	1117 Participants n=5 Participants	3410 Participants n=4 Participants
Sex: Female, Male Male	286 Participants n=5 Participants	332 Participants n=7 Participants	334 Participants n=5 Participants	952 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	438 Participants n=5 Participants	482 Participants n=7 Participants	470 Participants n=5 Participants	1390 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1017 Participants n=5 Participants	974 Participants n=7 Participants	981 Participants n=5 Participants	2972 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	1128 Participants n=5 Participants	1126 Participants n=7 Participants	1099 Participants n=5 Participants	3353 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	63 Participants n=5 Participants	65 Participants n=7 Participants	83 Participants n=5 Participants	211 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	65 Participants n=5 Participants	56 Participants n=7 Participants	55 Participants n=5 Participants	176 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	199 Participants n=5 Participants	209 Participants n=7 Participants	214 Participants n=5 Participants	622 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to last contact date (maximum up to 72 months)

Population: SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi).

Incidence rate (number of participants with event per 100 participant year [PY]) was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Malignancy events, excluding NMSC were adjudicated by a steering committee. The risk period (RP) was the last contact date. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=2911 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi n=1451 Participants In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC)	1.13 participants with event/100 PY Interval 0.87 to 1.45	1.13 participants with event/100 PY Interval 0.86 to 1.45	1.13 participants with event/100 PY Interval 0.94 to 1.35	0.77 participants with event/100 PY Interval 0.55 to 1.04

PRIMARY outcome

Timeframe: Baseline up to last contact date (maximum up to 72 months)

Population: SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi).

MACE included the cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke of any classification, including reversible focal neurologic defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=2911 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi n=1451 Participants In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE)	0.91 participants with event/100 PY Interval 0.67 to 1.21	1.05 participants with event/100 PY Interval 0.78 to 1.38	0.98 participants with event/100 PY Interval 0.79 to 1.19	0.73 participants with event/100 PY Interval 0.52 to 1.01

SECONDARY outcome

Timeframe: Baseline up to last contact date (maximum up to 72 months)

Population: SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi).

Non-fatal stroke included reversible focal neurologic defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Incidence Rate of Non-fatal Stroke	0.27 participants with event/100 PY Interval 0.15 to 0.45	0.33 participants with event/100 PY Interval 0.19 to 0.53	0.34 participants with event/100 PY Interval 0.2 to 0.54	—

SECONDARY outcome

Timeframe: Baseline up to last contact date (maximum up to 72 months)

Population: SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi).

Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Incidence Rate of Non-fatal Myocardial Infarction	0.37 participants with event/100 PY Interval 0.22 to 0.57	0.33 participants with event/100 PY Interval 0.19 to 0.53	0.16 participants with event/100 PY Interval 0.07 to 0.31	—

SECONDARY outcome

Timeframe: Baseline up to last contact date (maximum up to 72 months)

Population: SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi).

Opportunistic infections (OI) were reviewed and adjudicated by the opportunistic infection review committee (OIRC). Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Incidence Rate of Adjudicated Opportunistic Infection Events Including Tuberculosis	0.76 participants with event/100 PY Interval 0.54 to 1.04	0.91 participants with event/100 PY Interval 0.66 to 1.22	0.42 participants with event/100 PY Interval 0.26 to 0.64	—

SECONDARY outcome

Timeframe: Baseline up to last contact date (maximum up to 72 months)

Population: SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi).

Hepatic events (adjudicated) included drug-induced liver injury (DILI) - probable, highly likely and definite, DILI - listed separately, DILI - cases meeting classification and severity, participants with elevations of transaminase levels greater than (>) 1* upper limit of normal (ULN), greater than or equal to (>=) 3*ULN, >=5*ULN (based on laboratory values). Incidence rate was the total number of participants with admissible events divided by total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was minimum of The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. Last contact date was maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). In case of death, last contact date was death date. First events counted within RP. Participant did not have an event or had an event outside risk period were censored at end of RP.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Incidence Rate of Adjudicated Hepatic Events	0.90 participants with event/100 PY Interval 0.66 to 1.2	1.51 participants with event/100 PY Interval 1.18 to 1.91	0.70 participants with event/100 PY Interval 0.49 to 0.97	—

SECONDARY outcome

Timeframe: Baseline up to last contact date (maximum up to 72 months)

Population: SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi).

Cardiovascular events (adjudicated) were death (coronary and non-coronary), MI, all coronary revascularization, unstable angina, new ischemic heart disease, stroke (fatal and non-fatal), transient ischemic attack (TIA), congestive heart failure (CHF), peripheral arterial vascular disease (PAVD), deep vein thrombosis, pulmonary embolism, arterial embolism, arterial thrombosis. Incidence rate was total number of participants with admissible events divided by total (for all qualifying participants) time at risk for cohort/treatment group of interest. Risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. Last contact date was maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). In case of death, last contact date was death date. First events counted within RP. Participant did not have an event or had an event outside risk period were censored at end of RP.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Incidence Rate of Adjudicated Cardiovascular Events Other Than Major Adverse Cardiovascular Events (MACE)	1.21 participants with event/100 PY Interval 0.92 to 1.55	1.45 participants with event/100 PY Interval 1.13 to 1.83	1.05 participants with event/100 PY Interval 0.78 to 1.38	—

SECONDARY outcome

Timeframe: AEs: Baseline up to minimum of last contact date or last study treatment dose date+28 days (maximum up to 72 months); SAEs: Baseline up to minimum of last contact date (maximum up to 72 months)

Population: SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi).

AE was any untoward medical occurrence post treatment; event need not necessarily had causal relationship with treatment or usage. SAE: any untoward medical occurrence at any dose: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly. TEAE: event that occurred for first time during effective duration of treatment and not seen prior to start of treatment or event seen prior to start of treatment but increase in severity during treatment. Risk period (RP) for AE: minimum of last contact date or last study treatment dose date+28 days. RP for SAEs: last contact date. Last contact date was maximum: AE start, AE stop, last study visit, withdrawal and telephone contact. In case of death, last contact was death date. First events counted within RP. Participant did not have event or had event outside risk period were censored at end of RP.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	1333 Participants	1344 Participants	1308 Participants	—
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	373 Participants	420 Participants	339 Participants	—

SECONDARY outcome

Timeframe: Baseline up to last contact date (maximum up to 72 months)

Population: Analysis population included all participants from SAS with an abnormal baseline with at least one observation of the given laboratory test while on study treatment or during lag time.

Clinically significant laboratory abnormalities: Hematology: hemoglobin, hematocrit, erythrocytes with primary criteria as less than [<] 0.8* lower limit of normal [LLN]), platelets (<0.5* LLN; >1.75* ULN), leukocytes (<0.6*LLN; >1.5*ULN), lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes (<0.8*LLN; >1.2*ULN), eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes (>1.2*ULN); urinalysis: urine glucose, urine protein, urine hemoglobin, and leukocyte esterase (>=1); chemistry: bilirubin, indirect bilirubin (>1.5*ULN) aspartate aminotransferase, alanine aminotransferase (>3.0*ULN), creatinine, triglycerides, cholesterol (>1.3*ULN) and HDL cholesterol (<0.8*LLN). Risk period (RP) was minimum of last contact date or last study treatment dose date+28 days. Last contact date was (date of death or maximum of dates: AE start, AE stop, last study visit, withdrawal, telephone contact). Participants without event or event outside RP were censored at end of RP.

Outcome measures

Measure	Tofacitinib 5 mg BID n=919 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=911 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=915 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Number of Participants With Clinically Significant Abnormal Laboratory Parameters	238 Participants	252 Participants	167 Participants	—

SECONDARY outcome

Timeframe: Baseline up to last contact date (maximum up to 72 months)

Population: SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi).

All-cause death was defined as the death due to any cause during the course of study. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Incidence rate of all-cause deaths (adjudicated by Adjudication Committee) was reported in this outcome measure. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Incidence Rate of Adjudicated All-Cause Deaths Deaths-Total	0.50 participants with event/100 PY Interval 0.33 to 0.74	0.80 participants with event/100 PY Interval 0.57 to 1.09	0.34 participants with event/100 PY Interval 0.2 to 0.54	—
Incidence Rate of Adjudicated All-Cause Deaths Deaths - Infections	0.08 participants with event/100 PY Interval 0.02 to 0.2	0.18 participants with event/100 PY Interval 0.08 to 0.35	0.06 participants with event/100 PY Interval 0.01 to 0.17	—
Incidence Rate of Adjudicated All-Cause Deaths Deaths - Cardiovascular Events	0.25 participants with event/100 PY Interval 0.13 to 0.43	0.41 participants with event/100 PY Interval 0.25 to 0.63	0.20 participants with event/100 PY Interval 0.1 to 0.36	—
Incidence Rate of Adjudicated All-Cause Deaths Deaths - Malignancies	0.10 participants with event/100 PY Interval 0.03 to 0.23	0.00 participants with event/100 PY Interval 0.0 to 0.08	0.02 participants with event/100 PY Interval 0.0 to 0.11	—
Incidence Rate of Adjudicated All-Cause Deaths Deaths - Other Causes	0.08 participants with event/100 PY Interval 0.02 to 0.2	0.21 participants with event/100 PY Interval 0.1 to 0.38	0.06 participants with event/100 PY Interval 0.01 to 0.17	—

SECONDARY outcome

Timeframe: Baseline up to last contact date (maximum up to 72 months)

Population: SAS included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi).

Number of participants who permanent or temporary discontinued study medication due to any AE, treatment related AEs, Coronavirus disease 2019 (COVID 19) related AEs, and herpes zoster were reported. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication Permanent discontinuation: AE	210 Participants	304 Participants	210 Participants	—
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication Temporary discontinuation: AEs	665 Participants	736 Participants	576 Participants	—
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication Permanent discontinuation: treatment related AE	111 Participants	179 Participants	114 Participants	—
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication Temporary discontinuation: treatment related AE	407 Participants	458 Participants	297 Participants	—
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication Permanent discontinuation: COVID-19 Related AEs	0 Participants	1 Participants	0 Participants	—
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication Temporary discontinuation: COVID-19 Related AEs	0 Participants	1 Participants	1 Participants	—
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication Permanent discontinuation: Herpes Zoster	6 Participants	13 Participants	2 Participants	—
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication Temporary discontinuation: Herpes Zoster	104 Participants	110 Participants	33 Participants	—

SECONDARY outcome

Timeframe: Baseline, Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63

Population: Full Analysis Set (FAS): all participants randomized and received at least one dose of drug. Mixed model for repeated measures used without imputation for missing values. Analyses included data while participants were receiving drug. Only visits with N \> 50 participants in each treatment group included in analyses. Number of Participants Analyzed: number of participants included in mixed model for repeated measures. Number Analyzed: number of participants evaluable for each specified time point.

DAS28 is a measure of disease activity in participants with rheumatoid arthritis based on a 28-joint assessment. DAS28-4 (CRP) was calculated from number of painful joints out of 28 joints (TJC28) and number of swollen joints out of 28 joints (SJC28), CRP (milligrams per liter [mg/L]) and patient's global assessment of disease activity (PtGA) on a 100 mm Visual Analog Scale (VAS) (scores ranging from 0 millimeter [mm] [very well] to 100 mm [worst], higher scores indicated worse health condition). Total DAS28-4 (CRP) score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 indicates low disease activity and > 3.2 to <=5.1 indicates moderate disease activity, >5.1 indicates high disease activity, and DAS28-4 (CRP) < 2.6 indicates remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96; ln = natural logarithm, sqrt = square root.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1409 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1391 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1386 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 9	-2.64 units on a scale Standard Error 0.03	-2.80 units on a scale Standard Error 0.03	-2.54 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 12	-2.70 units on a scale Standard Error 0.03	-2.85 units on a scale Standard Error 0.03	-2.60 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 15	-2.78 units on a scale Standard Error 0.03	-2.93 units on a scale Standard Error 0.03	-2.67 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 18	-2.78 units on a scale Standard Error 0.03	-2.95 units on a scale Standard Error 0.03	-2.76 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 21	-2.82 units on a scale Standard Error 0.03	-2.97 units on a scale Standard Error 0.03	-2.76 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 24	-2.82 units on a scale Standard Error 0.03	-2.99 units on a scale Standard Error 0.03	-2.77 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 27	-2.91 units on a scale Standard Error 0.03	-3.03 units on a scale Standard Error 0.03	-2.81 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 30	-2.92 units on a scale Standard Error 0.03	-3.03 units on a scale Standard Error 0.03	-2.89 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 39	-2.96 units on a scale Standard Error 0.03	-2.97 units on a scale Standard Error 0.03	-2.91 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 2	-2.00 units on a scale Standard Error 0.03	-2.14 units on a scale Standard Error 0.03	-1.89 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 3	-2.28 units on a scale Standard Error 0.03	-2.42 units on a scale Standard Error 0.03	-2.19 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 6	-2.50 units on a scale Standard Error 0.03	-2.68 units on a scale Standard Error 0.03	-2.40 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 33	-2.89 units on a scale Standard Error 0.03	-3.03 units on a scale Standard Error 0.03	-2.89 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 36	-2.91 units on a scale Standard Error 0.03	-2.98 units on a scale Standard Error 0.03	-2.88 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 42	-2.95 units on a scale Standard Error 0.03	-3.05 units on a scale Standard Error 0.03	-2.93 units on a scale Standard Error 0.03	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 45	-2.94 units on a scale Standard Error 0.04	-2.96 units on a scale Standard Error 0.04	-2.97 units on a scale Standard Error 0.04	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 48	-2.98 units on a scale Standard Error 0.04	-2.99 units on a scale Standard Error 0.04	-2.93 units on a scale Standard Error 0.04	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 51	-3.00 units on a scale Standard Error 0.04	-2.95 units on a scale Standard Error 0.04	-2.96 units on a scale Standard Error 0.04	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 54	-2.99 units on a scale Standard Error 0.04	-3.01 units on a scale Standard Error 0.05	-2.99 units on a scale Standard Error 0.05	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 57	-2.97 units on a scale Standard Error 0.05	-2.93 units on a scale Standard Error 0.05	-3.02 units on a scale Standard Error 0.05	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 60	-3.09 units on a scale Standard Error 0.06	-2.94 units on a scale Standard Error 0.06	-3.01 units on a scale Standard Error 0.06	—
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 63	-3.07 units on a scale Standard Error 0.08	-2.99 units on a scale Standard Error 0.07	-3.05 units on a scale Standard Error 0.08	—

SECONDARY outcome

Timeframe: Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63

Population: FAS: all participants randomized and received at least one dose of drug. Mixed model for repeated measures used without imputation for missing values. Analyses included data while participants were receiving drug. Only visits with N \> 50 participants in each treatment group included in analyses. Number of Participants Analyzed: number of participants included in mixed model for repeated measures. Number Analyzed: number of participants evaluable for each specified time point.

SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and physician's global assessment of health (PhyGA) both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1378 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1356 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1346 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at month 27	-31.16 units on a scale Standard Error 0.25	-31.85 units on a scale Standard Error 0.26	-30.53 units on a scale Standard Error 0.26	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 39	-31.77 units on a scale Standard Error 0.25	-31.51 units on a scale Standard Error 0.26	-31.36 units on a scale Standard Error 0.26	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 2	-22.95 units on a scale Standard Error 0.33	-23.84 units on a scale Standard Error 0.33	-22.24 units on a scale Standard Error 0.33	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 3	-25.73 units on a scale Standard Error 0.30	-26.81 units on a scale Standard Error 0.30	-25.26 units on a scale Standard Error 0.30	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 6	-27.63 units on a scale Standard Error 0.28	-28.93 units on a scale Standard Error 0.28	-27.21 units on a scale Standard Error 0.28	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 9	-28.81 units on a scale Standard Error 0.28	-30.07 units on a scale Standard Error 0.28	-28.29 units on a scale Standard Error 0.28	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 12	-29.56 units on a scale Standard Error 0.27	-30.46 units on a scale Standard Error 0.27	-28.71 units on a scale Standard Error 0.27	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 15	-30.20 units on a scale Standard Error 0.25	-31.15 units on a scale Standard Error 0.26	-29.30 units on a scale Standard Error 0.26	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 18	-30.14 units on a scale Standard Error 0.26	-31.29 units on a scale Standard Error 0.26	-30.18 units on a scale Standard Error 0.26	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 21	-30.42 units on a scale Standard Error 0.26	-31.46 units on a scale Standard Error 0.26	-30.36 units on a scale Standard Error 0.26	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 24	-30.51 units on a scale Standard Error 0.26	-31.56 units on a scale Standard Error 0.26	-30.33 units on a scale Standard Error 0.26	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 30	-31.27 units on a scale Standard Error 0.25	-32.02 units on a scale Standard Error 0.25	-31.24 units on a scale Standard Error 0.25	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 33	-31.06 units on a scale Standard Error 0.26	-31.91 units on a scale Standard Error 0.26	-31.20 units on a scale Standard Error 0.26	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 36	-31.26 units on a scale Standard Error 0.26	-31.52 units on a scale Standard Error 0.27	-31.09 units on a scale Standard Error 0.26	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 42	-31.62 units on a scale Standard Error 0.27	-32.09 units on a scale Standard Error 0.28	-31.24 units on a scale Standard Error 0.27	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 45	-31.27 units on a scale Standard Error 0.29	-31.67 units on a scale Standard Error 0.30	-31.85 units on a scale Standard Error 0.30	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 48	-31.87 units on a scale Standard Error 0.31	-31.59 units on a scale Standard Error 0.32	-31.68 units on a scale Standard Error 0.32	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 51	-32.15 units on a scale Standard Error 0.33	-31.52 units on a scale Standard Error 0.34	-31.72 units on a scale Standard Error 0.34	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 54	-31.91 units on a scale Standard Error 0.33	-32.33 units on a scale Standard Error 0.35	-31.95 units on a scale Standard Error 0.35	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 57	-31.58 units on a scale Standard Error 0.41	-31.61 units on a scale Standard Error 0.42	-31.98 units on a scale Standard Error 0.42	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 60	-32.84 units on a scale Standard Error 0.46	-31.57 units on a scale Standard Error 0.46	-32.23 units on a scale Standard Error 0.48	—
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 63	-32.27 units on a scale Standard Error 0.63	-32.12 units on a scale Standard Error 0.62	-32.27 units on a scale Standard Error 0.66	—

SECONDARY outcome

Timeframe: Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63

Population: FAS: all participants randomized and received at least one dose of drug. Mixed model for repeated measures used without imputation for missing values. Analyses included data while participants were receiving drug. Only visits with N \> 50 participants in each treatment group included in analyses. Number of Participants Analyzed: number of participants included in mixed model for repeated measures. Number Analyzed: number of participants evaluable for each specified time point.

CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1378 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1356 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1348 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 48	-30.85 units on a scale Standard Error 0.30	-30.57 units on a scale Standard Error 0.32	-30.69 units on a scale Standard Error 0.31	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 2	-21.99 units on a scale Standard Error 0.32	-22.84 units on a scale Standard Error 0.32	-21.30 units on a scale Standard Error 0.32	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 3	-24.76 units on a scale Standard Error 0.29	-25.77 units on a scale Standard Error 0.29	-24.29 units on a scale Standard Error 0.30	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 6	-26.59 units on a scale Standard Error 0.27	-27.82 units on a scale Standard Error 0.28	-26.21 units on a scale Standard Error 0.28	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 9	-27.78 units on a scale Standard Error 0.27	-29.03 units on a scale Standard Error 0.27	-27.30 units on a scale Standard Error 0.27	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 12	-28.52 units on a scale Standard Error 0.26	-29.38 units on a scale Standard Error 0.26	-27.73 units on a scale Standard Error 0.26	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 15	-29.17 units on a scale Standard Error 0.25	-30.06 units on a scale Standard Error 0.25	-28.38 units on a scale Standard Error 0.25	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 18	-29.12 units on a scale Standard Error 0.25	-30.21 units on a scale Standard Error 0.26	-29.15 units on a scale Standard Error 0.25	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 21	-29.45 units on a scale Standard Error 0.25	-30.49 units on a scale Standard Error 0.26	-29.40 units on a scale Standard Error 0.25	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 24	-29.54 units on a scale Standard Error 0.25	-30.49 units on a scale Standard Error 0.26	-29.39 units on a scale Standard Error 0.25	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 27	-30.16 units on a scale Standard Error 0.24	-30.82 units on a scale Standard Error 0.25	-29.54 units on a scale Standard Error 0.25	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 30	-30.27 units on a scale Standard Error 0.24	-30.99 units on a scale Standard Error 0.25	-30.24 units on a scale Standard Error 0.25	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 33	-30.05 units on a scale Standard Error 0.25	-30.85 units on a scale Standard Error 0.25	-30.23 units on a scale Standard Error 0.25	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 36	-30.29 units on a scale Standard Error 0.25	-30.50 units on a scale Standard Error 0.26	-30.14 units on a scale Standard Error 0.25	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 39	-30.78 units on a scale Standard Error 0.24	-30.49 units on a scale Standard Error 0.25	-30.35 units on a scale Standard Error 0.25	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 42	-30.66 units on a scale Standard Error 0.26	-31.05 units on a scale Standard Error 0.27	-30.25 units on a scale Standard Error 0.26	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 45	-30.28 units on a scale Standard Error 0.28	-30.68 units on a scale Standard Error 0.29	-30.83 units on a scale Standard Error 0.29	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 51	-31.09 units on a scale Standard Error 0.32	-30.50 units on a scale Standard Error 0.33	-30.74 units on a scale Standard Error 0.33	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 54	-31.03 units on a scale Standard Error 0.32	-31.38 units on a scale Standard Error 0.33	-31.02 units on a scale Standard Error 0.33	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 57	-30.62 units on a scale Standard Error 0.40	-30.75 units on a scale Standard Error 0.41	-30.95 units on a scale Standard Error 0.41	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 60	-31.74 units on a scale Standard Error 0.45	-30.57 units on a scale Standard Error 0.45	-31.31 units on a scale Standard Error 0.47	—
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 63	-31.23 units on a scale Standard Error 0.58	-31.08 units on a scale Standard Error 0.57	-31.65 units on a scale Standard Error 0.60	—

SECONDARY outcome

Timeframe: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72

Population: FAS included all participants randomized in study and received at least one dose of randomized investigational drug. Analyses included data while participants were receiving the study drug. 'Number Analyzed' signifies number of participants evaluable for each specified time point. Last Observation Carried Forward (LOCF) applied for missing components and composite binary outcome was calculated. The percentages were calculated using numbers of participants evaluable at each visit as denominators.

ACR-EULAR Boolean-based definition of remission participant must satisfy all of the following: TJC28 <=1, SJC28 <=1, CRP <=10 mg/L, PtGA on a 0-100 mm scale, higher scores indicate greater affection due to disease activity.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 6	9.10 percentage of participants	10.66 percentage of participants	7.80 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 36	14.51 percentage of participants	16.18 percentage of participants	14.53 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 39	13.78 percentage of participants	14.30 percentage of participants	15.15 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 45	14.89 percentage of participants	15.46 percentage of participants	15.74 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 60	11.31 percentage of participants	12.73 percentage of participants	15.58 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 42	14.79 percentage of participants	15.41 percentage of participants	15.01 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 48	15.14 percentage of participants	13.90 percentage of participants	17.28 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 63	11.76 percentage of participants	16.96 percentage of participants	15.25 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 66	9.02 percentage of participants	16.79 percentage of participants	13.11 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 69	13.04 percentage of participants	19.57 percentage of participants	14.58 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 72	8.33 percentage of participants	22.22 percentage of participants	13.33 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 51	14.33 percentage of participants	15.50 percentage of participants	16.26 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 54	14.01 percentage of participants	16.42 percentage of participants	16.36 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 57	15.54 percentage of participants	14.16 percentage of participants	15.08 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 2	3.83 percentage of participants	4.99 percentage of participants	3.22 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 3	5.73 percentage of participants	7.72 percentage of participants	6.10 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 9	10.85 percentage of participants	12.60 percentage of participants	8.96 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 12	11.22 percentage of participants	13.06 percentage of participants	9.12 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 15	12.56 percentage of participants	15.18 percentage of participants	10.28 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 18	12.10 percentage of participants	16.04 percentage of participants	11.78 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 21	12.90 percentage of participants	15.22 percentage of participants	13.45 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 24	13.60 percentage of participants	15.99 percentage of participants	13.35 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 27	13.24 percentage of participants	17.59 percentage of participants	14.82 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 30	13.46 percentage of participants	16.96 percentage of participants	14.31 percentage of participants	—
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria Month 33	13.88 percentage of participants	15.97 percentage of participants	14.82 percentage of participants	—

SECONDARY outcome

Timeframe: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72

Population: FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated. The percentages were calculated using the numbers of participants evaluable at each visit as the denominators.

SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 12	15.89 percentage of participants	18.69 percentage of participants	13.92 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 15	18.26 percentage of participants	20.29 percentage of participants	15.90 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 18	18.68 percentage of participants	21.96 percentage of participants	16.79 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 2	4.62 percentage of participants	7.03 percentage of participants	4.15 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 3	9.19 percentage of participants	11.14 percentage of participants	7.84 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 6	12.38 percentage of participants	14.23 percentage of participants	10.40 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 9	15.90 percentage of participants	17.72 percentage of participants	12.75 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 21	20.89 percentage of participants	22.07 percentage of participants	17.93 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 39	22.99 percentage of participants	24.21 percentage of participants	21.48 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 45	25.27 percentage of participants	23.20 percentage of participants	23.26 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 51	23.35 percentage of participants	23.85 percentage of participants	24.24 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 54	22.34 percentage of participants	24.09 percentage of participants	24.55 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 60	18.65 percentage of participants	20.30 percentage of participants	25.23 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 24	20.44 percentage of participants	22.76 percentage of participants	18.93 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 27	21.91 percentage of participants	23.62 percentage of participants	21.12 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 30	21.31 percentage of participants	23.68 percentage of participants	21.91 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 33	21.43 percentage of participants	25.06 percentage of participants	22.19 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 36	22.47 percentage of participants	24.35 percentage of participants	21.80 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 42	24.59 percentage of participants	24.23 percentage of participants	23.41 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 48	25.32 percentage of participants	23.20 percentage of participants	24.20 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 57	24.10 percentage of participants	23.82 percentage of participants	24.83 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 63	19.00 percentage of participants	23.48 percentage of participants	23.32 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 66	14.75 percentage of participants	21.37 percentage of participants	20.49 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 69	17.39 percentage of participants	17.39 percentage of participants	22.92 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 Month 72	16.67 percentage of participants	22.22 percentage of participants	13.33 percentage of participants	—

SECONDARY outcome

Timeframe: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72

Population: FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated. The percentages were calculated using the numbers of participants evaluable at each visit as the denominators.

CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 3	9.26 percentage of participants	11.06 percentage of participants	7.76 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 12	16.33 percentage of participants	18.62 percentage of participants	14.64 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 18	19.82 percentage of participants	22.12 percentage of participants	17.93 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 36	23.22 percentage of participants	25.30 percentage of participants	21.64 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 48	25.55 percentage of participants	24.44 percentage of participants	24.31 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 66	13.93 percentage of participants	22.14 percentage of participants	17.21 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 69	19.57 percentage of participants	19.57 percentage of participants	18.75 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 72	16.67 percentage of participants	22.22 percentage of participants	13.33 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 2	4.70 percentage of participants	7.40 percentage of participants	4.36 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 6	12.87 percentage of participants	14.31 percentage of participants	10.32 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 9	15.76 percentage of participants	18.09 percentage of participants	13.25 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 15	18.03 percentage of participants	21.36 percentage of participants	16.41 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 21	21.35 percentage of participants	22.55 percentage of participants	18.70 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 24	20.44 percentage of participants	22.76 percentage of participants	19.48 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 27	22.77 percentage of participants	23.29 percentage of participants	21.51 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 30	21.88 percentage of participants	24.18 percentage of participants	22.31 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 33	22.24 percentage of participants	25.91 percentage of participants	22.36 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 39	23.92 percentage of participants	24.30 percentage of participants	21.90 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 42	25.02 percentage of participants	24.95 percentage of participants	23.66 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 45	25.95 percentage of participants	24.23 percentage of participants	23.85 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 51	24.50 percentage of participants	24.89 percentage of participants	25.11 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 54	23.23 percentage of participants	25.00 percentage of participants	25.45 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 57	24.32 percentage of participants	24.04 percentage of participants	25.75 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 60	19.88 percentage of participants	20.91 percentage of participants	26.48 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 Month 63	20.81 percentage of participants	22.17 percentage of participants	22.87 percentage of participants	—

SECONDARY outcome

Timeframe: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72

Population: FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated. The percentages were calculated using the numbers of participants evaluable at each visit as the denominators.

SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 6	50.85 percentage of participants	53.56 percentage of participants	45.80 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 9	56.40 percentage of participants	59.82 percentage of participants	52.90 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 12	57.87 percentage of participants	61.11 percentage of participants	54.93 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 18	62.10 percentage of participants	65.19 percentage of participants	60.41 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 48	67.28 percentage of participants	64.76 percentage of participants	67.94 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 69	60.87 percentage of participants	65.22 percentage of participants	68.75 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 2	30.76 percentage of participants	35.02 percentage of participants	28.08 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 3	41.47 percentage of participants	45.00 percentage of participants	37.99 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 15	61.12 percentage of participants	63.92 percentage of participants	57.39 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 21	62.75 percentage of participants	65.26 percentage of participants	61.21 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 24	63.17 percentage of participants	66.15 percentage of participants	61.59 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 27	65.17 percentage of participants	66.97 percentage of participants	63.67 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 30	67.23 percentage of participants	68.35 percentage of participants	65.64 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 33	65.75 percentage of participants	68.82 percentage of participants	65.36 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 36	67.33 percentage of participants	66.61 percentage of participants	65.48 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 39	69.74 percentage of participants	67.11 percentage of participants	66.03 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 42	68.96 percentage of participants	70.72 percentage of participants	66.41 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 45	68.36 percentage of participants	68.97 percentage of participants	67.55 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 51	67.91 percentage of participants	67.51 percentage of participants	67.78 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 54	64.89 percentage of participants	68.61 percentage of participants	68.00 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 57	63.51 percentage of participants	66.29 percentage of participants	68.21 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 60	63.30 percentage of participants	66.67 percentage of participants	64.17 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 63	61.54 percentage of participants	68.26 percentage of participants	64.57 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 66	59.02 percentage of participants	71.76 percentage of participants	59.02 percentage of participants	—
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11 Month 72	50.00 percentage of participants	66.67 percentage of participants	60.00 percentage of participants	—

SECONDARY outcome

Timeframe: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72

Population: FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated. The percentages were calculated using the numbers of participants evaluable at each visit as the denominators.

CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 12	56.56 percentage of participants	59.38 percentage of participants	53.57 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 45	67.97 percentage of participants	68.66 percentage of participants	67.16 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 48	66.71 percentage of participants	63.15 percentage of participants	67.58 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 51	67.77 percentage of participants	65.87 percentage of participants	67.63 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 60	63.00 percentage of participants	65.15 percentage of participants	65.42 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 69	58.70 percentage of participants	65.22 percentage of participants	66.67 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 72	50.00 percentage of participants	66.67 percentage of participants	53.33 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 2	29.47 percentage of participants	34.25 percentage of participants	26.92 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 3	40.07 percentage of participants	43.90 percentage of participants	35.99 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 6	49.36 percentage of participants	51.83 percentage of participants	43.63 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 9	55.40 percentage of participants	58.78 percentage of participants	50.91 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 15	60.31 percentage of participants	62.70 percentage of participants	55.93 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 18	60.51 percentage of participants	64.02 percentage of participants	59.42 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 21	61.37 percentage of participants	64.94 percentage of participants	60.20 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 24	62.78 percentage of participants	65.25 percentage of participants	61.19 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 27	64.93 percentage of participants	66.39 percentage of participants	62.87 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 30	67.15 percentage of participants	67.84 percentage of participants	65.00 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 33	65.50 percentage of participants	67.71 percentage of participants	65.03 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 36	66.67 percentage of participants	65.15 percentage of participants	64.66 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 39	68.64 percentage of participants	66.40 percentage of participants	65.61 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 42	68.44 percentage of participants	69.10 percentage of participants	65.82 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 54	64.54 percentage of participants	67.88 percentage of participants	68.00 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 57	62.61 percentage of participants	65.39 percentage of participants	67.98 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 63	62.90 percentage of participants	66.52 percentage of participants	66.37 percentage of participants	—
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10 Month 66	57.38 percentage of participants	67.94 percentage of participants	61.48 percentage of participants	—

SECONDARY outcome

Timeframe: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72

Population: FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated. The percentages were calculated using the numbers of participants evaluable at each visit as the denominators.

DAS28 is a measure of disease activity in participants with rheumatoid arthritis based on a 28-joint assessment. DAS28-4 (CRP) was calculated from number of painful joints out of 28 joints (TJC28) and number of swollen joints out of 28 joints (SJC28), CRP (mg/L) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicated worse health condition). Total DAS28-4 (CRP) score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 indicates low disease activity and > 3.2 to <=5.1 indicates moderate disease activity, >5.1 indicates high disease activity, and DAS28-4 (CRP) < 2.6 indicates remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 69	58.70 percentage of participants	56.52 percentage of participants	70.83 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 72	50.00 percentage of participants	61.11 percentage of participants	73.33 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 9	56.11 percentage of participants	59.01 percentage of participants	50.91 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 21	62.29 percentage of participants	63.67 percentage of participants	59.27 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 27	64.22 percentage of participants	67.63 percentage of participants	60.56 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 30	64.66 percentage of participants	65.49 percentage of participants	63.22 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 33	63.80 percentage of participants	66.02 percentage of participants	62.82 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 36	64.43 percentage of participants	64.63 percentage of participants	62.59 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 39	65.85 percentage of participants	65.18 percentage of participants	63.53 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 42	65.43 percentage of participants	67.93 percentage of participants	65.31 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 45	64.74 percentage of participants	65.77 percentage of participants	64.52 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 48	64.39 percentage of participants	64.52 percentage of participants	64.36 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 51	65.19 percentage of participants	66.47 percentage of participants	65.46 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 54	64.18 percentage of participants	66.24 percentage of participants	66.55 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 57	63.06 percentage of participants	63.60 percentage of participants	67.29 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 60	62.69 percentage of participants	64.24 percentage of participants	65.11 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 63	60.18 percentage of participants	64.35 percentage of participants	68.61 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 2	31.55 percentage of participants	35.57 percentage of participants	28.36 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 3	41.68 percentage of participants	46.05 percentage of participants	37.54 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 6	50.28 percentage of participants	54.87 percentage of participants	44.88 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 12	57.73 percentage of participants	60.06 percentage of participants	53.05 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 15	60.38 percentage of participants	63.54 percentage of participants	55.03 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 18	61.72 percentage of participants	63.86 percentage of participants	58.51 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 24	61.93 percentage of participants	64.11 percentage of participants	59.78 percentage of participants	—
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2 Month 66	55.74 percentage of participants	66.41 percentage of participants	60.66 percentage of participants	—

SECONDARY outcome

Timeframe: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72

Population: FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated.

ACR20 response is a >= 20% improvement in TJC (28) and SJC (28) and >=20% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 2	832 Participants	867 Participants	812 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 6	999 Participants	1012 Participants	981 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 9	1019 Participants	1004 Participants	987 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 12	1033 Participants	992 Participants	966 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 15	1017 Participants	1003 Participants	969 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 18	981 Participants	974 Participants	937 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 21	955 Participants	953 Participants	949 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 24	956 Participants	922 Participants	922 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 27	961 Participants	917 Participants	913 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 30	932 Participants	899 Participants	931 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 33	935 Participants	888 Participants	922 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 36	907 Participants	881 Participants	887 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 39	896 Participants	843 Participants	887 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 42	905 Participants	848 Participants	883 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 45	780 Participants	718 Participants	790 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 48	654 Participants	587 Participants	639 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 54	434 Participants	396 Participants	400 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 57	337 Participants	321 Participants	302 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 60	243 Participants	237 Participants	232 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 63	163 Participants	166 Participants	161 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 66	85 Participants	101 Participants	89 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 69	26 Participants	36 Participants	37 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 51	535 Participants	485 Participants	518 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 72	5 Participants	15 Participants	10 Participants	—
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response Month 3	979 Participants	992 Participants	923 Participants	—

SECONDARY outcome

Timeframe: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72

Population: FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated.

ACR50 response is a >= 50% improvement in TJC (28) and SJC (28) and >=50% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 51	350 Participants	320 Participants	346 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 54	284 Participants	271 Participants	268 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 2	402 Participants	452 Participants	336 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 3	528 Participants	561 Participants	460 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 6	605 Participants	614 Participants	533 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 9	620 Participants	651 Participants	577 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 12	631 Participants	654 Participants	577 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 15	652 Participants	668 Participants	582 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 18	633 Participants	643 Participants	609 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 21	607 Participants	623 Participants	608 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 24	622 Participants	616 Participants	592 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 27	620 Participants	602 Participants	596 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 30	599 Participants	609 Participants	610 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 33	585 Participants	611 Participants	594 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 36	603 Participants	566 Participants	592 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 39	595 Participants	588 Participants	561 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 42	592 Participants	578 Participants	587 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 45	521 Participants	481 Participants	519 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 48	422 Participants	385 Participants	424 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 57	200 Participants	210 Participants	209 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 60	152 Participants	151 Participants	150 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 63	100 Participants	104 Participants	103 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 66	52 Participants	68 Participants	55 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 69	16 Participants	20 Participants	27 Participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) Response Month 72	3 Participants	6 Participants	7 Participants	—

SECONDARY outcome

Timeframe: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72

Population: FAS included all participants randomized in the study and received at least one dose of investigational drug. Analyses included the data while the participants were receiving the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for each specified time point. LOCF was applied for missing components, and then composite binary outcome was calculated.

ACR70 response is a >= 70% improvement in TJC (28) and SJC (28) and >=70% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1455 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1451 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 2	152 Participants	193 Participants	113 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 3	253 Participants	268 Participants	199 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 6	282 Participants	331 Participants	234 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 9	328 Participants	367 Participants	291 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 12	337 Participants	373 Participants	284 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 15	359 Participants	390 Participants	304 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 18	358 Participants	382 Participants	325 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 21	362 Participants	370 Participants	322 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 24	349 Participants	386 Participants	328 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 27	374 Participants	390 Participants	342 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 30	369 Participants	397 Participants	358 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 33	357 Participants	392 Participants	355 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 36	362 Participants	343 Participants	351 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 39	371 Participants	361 Participants	338 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 42	376 Participants	342 Participants	343 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 45	313 Participants	298 Participants	298 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 48	256 Participants	228 Participants	238 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 51	216 Participants	195 Participants	199 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 54	159 Participants	163 Participants	160 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 57	128 Participants	127 Participants	118 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 60	79 Participants	83 Participants	92 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 63	58 Participants	57 Participants	64 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 66	25 Participants	38 Participants	35 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 69	8 Participants	15 Participants	14 Participants	—
Number of Participants With an American College of Rheumatology 70% (ACR70) Response Month 72	2 Participants	5 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Baseline, Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63

Population: FAS: all participants randomized and received at least one dose of drug. Mixed model for repeated measures used without imputation for missing values. Analyses included data while participants were receiving drug. Only visits with N \> 50 participants in each treatment group included in analyses. Number of Participants Analyzed: number of participants included in mixed model for repeated measures. Number Analyzed: number of participants evaluable for each specified time point.

HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. There were total of 30 items distributed in these 8 domains. Each item was scored on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.

Outcome measures

Measure	Tofacitinib 5 mg BID n=1409 Participants Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1390 Participants Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	All Tofacitinib n=1388 Participants All participants who received treatment in either tofacitinib 5 mg or tofacitinib 10 mg group BID up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	TNFi In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 2	-0.42 units on a scale Standard Error 0.02	-0.45 units on a scale Standard Error 0.02	-0.38 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 54	-0.53 units on a scale Standard Error 0.02	-0.51 units on a scale Standard Error 0.02	-0.48 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 60	-0.52 units on a scale Standard Error 0.03	-0.49 units on a scale Standard Error 0.03	-0.48 units on a scale Standard Error 0.03	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 3	-0.45 units on a scale Standard Error 0.02	-0.48 units on a scale Standard Error 0.02	-0.42 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 6	-0.50 units on a scale Standard Error 0.02	-0.51 units on a scale Standard Error 0.02	-0.46 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 9	-0.51 units on a scale Standard Error 0.02	-0.55 units on a scale Standard Error 0.02	-0.47 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 12	-0.52 units on a scale Standard Error 0.02	-0.53 units on a scale Standard Error 0.02	-0.49 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 15	-0.53 units on a scale Standard Error 0.02	-0.56 units on a scale Standard Error 0.02	-0.51 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 18	-0.52 units on a scale Standard Error 0.02	-0.56 units on a scale Standard Error 0.02	-0.49 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 21	-0.53 units on a scale Standard Error 0.02	-0.55 units on a scale Standard Error 0.02	-0.50 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 24	-0.52 units on a scale Standard Error 0.02	-0.57 units on a scale Standard Error 0.02	-0.49 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 27	-0.52 units on a scale Standard Error 0.02	-0.56 units on a scale Standard Error 0.02	-0.51 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 30	-0.53 units on a scale Standard Error 0.02	-0.55 units on a scale Standard Error 0.02	-0.50 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 33	-0.51 units on a scale Standard Error 0.02	-0.56 units on a scale Standard Error 0.02	-0.52 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 36	-0.50 units on a scale Standard Error 0.02	-0.54 units on a scale Standard Error 0.02	-0.48 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 39	-0.51 units on a scale Standard Error 0.02	-0.54 units on a scale Standard Error 0.02	-0.49 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 42	-0.51 units on a scale Standard Error 0.02	-0.52 units on a scale Standard Error 0.02	-0.50 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 45	-0.50 units on a scale Standard Error 0.02	-0.51 units on a scale Standard Error 0.02	-0.51 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 48	-0.50 units on a scale Standard Error 0.02	-0.50 units on a scale Standard Error 0.02	-0.48 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 51	-0.53 units on a scale Standard Error 0.02	-0.49 units on a scale Standard Error 0.02	-0.50 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 57	-0.49 units on a scale Standard Error 0.02	-0.48 units on a scale Standard Error 0.02	-0.48 units on a scale Standard Error 0.02	—
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63 Change at Month 63	-0.54 units on a scale Standard Error 0.03	-0.48 units on a scale Standard Error 0.03	-0.48 units on a scale Standard Error 0.04	—

Adverse Events

Tofacitinib 5 mg BID

Serious events: 373 serious events

Other events: 1108 other events

Deaths: 49 deaths

Tofacitinib 10 mg BID

Serious events: 420 serious events

Other events: 1127 other events

Deaths: 66 deaths

TNFi

Serious events: 339 serious events

Other events: 1056 other events

Deaths: 38 deaths

Serious adverse events

Measure	Tofacitinib 5 mg BID n=1455 participants at risk Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 participants at risk Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	TNFi n=1451 participants at risk In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Anaemia	0.62% 9/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.27% 4/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Blood loss anaemia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Cytopenia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Haemolytic anaemia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Iron deficiency anaemia	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Leukocytosis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Leukopenia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Neutropenia	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Pancytopenia	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Acute coronary syndrome	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Acute left ventricular failure	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Angina pectoris	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Angina unstable	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Aortic valve disease	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Arrhythmia	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Arrhythmia supraventricular	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Atrial fibrillation	0.48% 7/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.55% 8/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.41% 6/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Atrial flutter	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Atrioventricular block	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Cardiac arrest	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.27% 4/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Cardiac failure	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Cardiac failure acute	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Cardiac failure chronic	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Cardiac failure congestive	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.41% 6/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Cardiac pseudoaneurysm	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Cardiomyopathy	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Chronic left ventricular failure	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Congestive cardiomyopathy	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Coronary artery disease	0.55% 8/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Coronary artery insufficiency	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Coronary artery occlusion	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Coronary artery stenosis	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Diastolic dysfunction	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Ischaemic cardiomyopathy	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Mitral valve disease	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Myocardial infarction	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Myocardial ischaemia	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Pericarditis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Right ventricular dysfunction	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Sinus node dysfunction	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Supraventricular tachycardia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Ventricular fibrillation	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Cardiac disorders Ventricular tachycardia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Congenital, familial and genetic disorders Corneal dystrophy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Congenital, familial and genetic disorders Exomphalos	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Ear and labyrinth disorders Acute vestibular syndrome	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Ear and labyrinth disorders Meniere's disease	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Ear and labyrinth disorders Vertigo	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Endocrine disorders Adrenal disorder	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Endocrine disorders Adrenal haematoma	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Endocrine disorders Hyperthyroidism	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Endocrine disorders Thyroid mass	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Eye disorders Cataract	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.41% 6/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Eye disorders Diabetic retinopathy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Eye disorders Episcleritis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Eye disorders Keratoconus	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Eye disorders Macular hole	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Eye disorders Necrotising retinitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Eye disorders Retinal detachment	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Eye disorders Retinal vasculitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Eye disorders Ulcerative keratitis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Eye disorders Uveitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Abdominal compartment syndrome	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Abdominal distension	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Abdominal hernia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Abdominal incarcerated hernia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Abdominal pain	0.34% 5/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Abdominal pain upper	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Ascites	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Chronic gastritis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Colitis	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Constipation	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Diarrhoea	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Diverticular perforation	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Duodenal stenosis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Dysphagia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Enteritis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Enterocolitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Faecaloma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Gastric polyps	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Gastric ulcer	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Gastritis	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Gastritis erosive	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Gastritis haemorrhagic	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Gastrointestinal erosion	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Gastrointestinal inflammation	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Haematochezia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Hiatus hernia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Ileus	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Impaired gastric emptying	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Inguinal hernia	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Intestinal obstruction	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Ischaemic enteritis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Jejunal ulcer	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Jejunal ulcer perforation	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Large intestine perforation	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Mallory-Weiss syndrome	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Melaena	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Nausea	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Obstruction gastric	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Obstructive pancreatitis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Obturator hernia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Oesophageal food impaction	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Oesophagitis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Pancreatitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Pancreatitis acute	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Pancreatitis haemorrhagic	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Peptic ulcer	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Peptic ulcer perforation	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Small intestinal obstruction	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Umbilical hernia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Vomiting	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Accidental death	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Adverse drug reaction	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Asthenia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Chest discomfort	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Chest pain	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Complication associated with device	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Death	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Device intolerance	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Drug intolerance	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Impaired healing	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Inflammation	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Mucosal inflammation	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Multiple organ dysfunction syndrome	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Non-cardiac chest pain	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Oedema peripheral	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Pyrexia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Sudden death	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
General disorders Systemic inflammatory response syndrome	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Bile duct stone	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Biliary colic	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Cholangitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Cholecystitis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Cholecystitis acute	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Cholelithiasis	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Cirrhosis alcoholic	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Gallbladder obstruction	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Gallbladder rupture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Hepatorenal failure	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Immune system disorders Anaphylactic reaction	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Immune system disorders Anaphylactic shock	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Immune system disorders Drug hypersensitivity	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Immune system disorders Hypersensitivity	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Abscess limb	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Acute pulmonary histoplasmosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Acute sinusitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Adenovirus infection	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Anal abscess	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Appendiceal abscess	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Appendicitis	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.27% 4/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Appendicitis perforated	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Arthritis bacterial	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.27% 4/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Arthritis infective	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Atypical pneumonia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Bacteraemia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Bacterial infection	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Bacterial sepsis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Bone tuberculosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Brain abscess	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Breast abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Bronchiolitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Bronchitis	0.69% 10/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.62% 9/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.48% 7/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Bronchitis bacterial	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Bronchitis viral	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Bursitis infective	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations COVID-19	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations COVID-19 pneumonia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Carbuncle	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Cellulitis	0.82% 12/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.89% 13/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	1.0% 15/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Cellulitis staphylococcal	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Cholecystitis infective	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Chorioretinitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Chronic sinusitis	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Clostridium difficile colitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Colonic abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Complicated appendicitis	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Cytomegalovirus chorioretinitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Cytomegalovirus infection	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Dengue fever	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Device related infection	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Diarrhoea infectious	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Disseminated tuberculosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Disseminated varicella zoster virus infection	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.27% 4/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Diverticulitis	0.48% 7/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.41% 6/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Encephalitis meningococcal	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Epididymitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Erysipelas	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Escherichia bacteraemia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Escherichia infection	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Escherichia pyelonephritis	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Escherichia sepsis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Escherichia urinary tract infection	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations External ear cellulitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Extradural abscess	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Eye infection	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Gangrene	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Gastroenteritis	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.48% 7/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Gastroenteritis bacterial	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Gastroenteritis viral	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Gastrointestinal infection	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations H1N1 influenza	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Herpes oesophagitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Herpes ophthalmic	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Herpes virus infection	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Herpes zoster	0.62% 9/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.76% 11/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Histoplasmosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Infected bite	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Infection	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Infectious pleural effusion	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Influenza	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Intervertebral discitis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Joint abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Liver abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Localised infection	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Lower respiratory tract infection	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Lung abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Lyme disease	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Medical device site joint infection	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Meningitis bacterial	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Meningoencephalitis herpetic	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Muscle abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Nail infection	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Neuroborreliosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Neurocryptococcosis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Orchitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Osteomyelitis	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Osteomyelitis acute	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Parainfluenzae virus infection	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Parotid abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Parotitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pelvic abscess	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pelvic inflammatory disease	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pericarditis tuberculous	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Perihepatic abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Peritoneal tuberculosis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Peritonitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pharyngitis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pneumocystis jirovecii pneumonia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pneumonia	3.4% 50/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	3.8% 56/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	3.0% 43/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pneumonia bacterial	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pneumonia fungal	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pneumonia influenzal	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pneumonia legionella	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pneumonia mycoplasmal	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pneumonia pneumococcal	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pneumonia staphylococcal	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Post procedural infection	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Post procedural pneumonia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Post procedural sepsis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Postoperative wound infection	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pulmonary tuberculosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pulpitis dental	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pyelonephritis	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pyelonephritis acute	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pyometra	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Rectal abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Renal abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Renal tuberculosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Respiratory tract infection	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Respiratory tract infection viral	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Retroperitoneal abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Salmonella sepsis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Sepsis	0.41% 6/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.41% 6/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Septic shock	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.62% 9/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Sinobronchitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Sinusitis fungal	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Soft tissue infection	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Staphylococcal sepsis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Systemic candida	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Tick-borne fever	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Tooth abscess	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Tracheobronchitis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Tuberculosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Tubo-ovarian abscess	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Upper respiratory tract infection	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Urinary tract infection	0.96% 14/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.96% 14/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.62% 9/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Urosepsis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Viral infection	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Wound infection	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Wound infection staphylococcal	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Wound sepsis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Acetabulum fracture	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Ankle fracture	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Back injury	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Central cord syndrome	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Complicated fracture	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Concussion	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Contusion	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Extradural haematoma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Fall	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Femoral neck fracture	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Femur fracture	0.69% 10/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.76% 11/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Forearm fracture	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Fracture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Graft complication	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Hand fracture	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Head injury	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Hip fracture	0.34% 5/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.27% 4/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Humerus fracture	0.34% 5/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Injury	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Joint dislocation	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Limb injury	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Lower limb fracture	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Meniscus injury	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Patella fracture	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Pelvic fracture	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Post laminectomy syndrome	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Postoperative wound complication	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Pulmonary contusion	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Radius fracture	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Respiratory fume inhalation disorder	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Skin laceration	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Skin wound	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Subarachnoid haematoma	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Tendon rupture	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Tibia fracture	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Transplant dysfunction	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Ulna fracture	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Upper limb fracture	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Wrist fracture	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations Alanine aminotransferase increased	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations Aspartate aminotransferase increased	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations Biopsy endometrium normal	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations Blood alkaline phosphatase increased	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations Blood creatine phosphokinase increased	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations Blood sodium decreased	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations Hepatic enzyme increased	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations International normalised ratio increased	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations Lymphocyte count decreased	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations Transaminases increased	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations Weight decreased	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Decreased appetite	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Dehydration	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Diabetes mellitus	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Fluid overload	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Hypercalcaemia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Hyperkalaemia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Hypochloraemia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Hypokalaemia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Hyponatraemia	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.27% 4/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Metabolism and nutrition disorders Vitamin D deficiency	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.48% 7/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Arthritis	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Back pain	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.27% 4/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Bone hypertrophy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Costochondritis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Exostosis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Foot deformity	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Hip deformity	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Joint contracture	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Joint destruction	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Knee deformity	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Kyphosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.0% 29/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	1.6% 23/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	1.1% 16/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.76% 11/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.69% 10/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.83% 12/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Spinal instability	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.27% 4/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Synovial disorder	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Tendon disorder	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Thoracic spinal stenosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal neoplasm	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder neoplasm	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal lymphoma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Heavy chain disease	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoproliferative disorder	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of pleura	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian granulosa cell tumour	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sweat gland tumour	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Waldenstrom's macroglobulinaemia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Amyotrophic lateral sclerosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Basilar artery stenosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Carotid artery occlusion	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Carotid artery stenosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Cerebral ischaemia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Cerebrovascular accident	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Cerebrovascular disorder	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Cervical cord compression	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Cervical radiculopathy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Coma hepatic	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Dementia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Diabetic neuropathy	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Dizziness	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Encephalopathy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Epilepsy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Facial paralysis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Headache	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.27% 4/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Hepatic encephalopathy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Hypoaesthesia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Hypoglycaemic seizure	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Intercostal neuralgia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Intracranial aneurysm	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Intracranial mass	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Ischaemic stroke	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Loss of consciousness	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Lumbar radiculopathy	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Metabolic encephalopathy	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Migraine	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Morton's neuralgia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Myelopathy	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Neuralgia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Paraesthesia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Peripheral sensorimotor neuropathy	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Post herpetic neuralgia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Postictal paralysis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Presyncope	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Progressive supranuclear palsy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Quadriplegia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Radiculopathy	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Restless legs syndrome	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Reversible ischaemic neurological deficit	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Ruptured cerebral aneurysm	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Sciatica	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Seizure	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Senile dementia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Spinal claudication	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Spondylitic myelopathy	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Status epilepticus	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Syncope	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Thecal sac compression	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Toxic encephalopathy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Transient ischaemic attack	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.55% 8/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Vascular encephalopathy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Product Issues Device dislocation	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Product Issues Device failure	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Product Issues Device loosening	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Product Issues Device occlusion	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Psychiatric disorders Anxiety	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Psychiatric disorders Completed suicide	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Psychiatric disorders Confusional state	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Psychiatric disorders Delirium	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Psychiatric disorders Depression	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Psychiatric disorders Major depression	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Psychiatric disorders Mental status changes	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Psychiatric disorders Psychotic disorder	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Psychiatric disorders Suicidal ideation	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Psychiatric disorders Suicide attempt	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Acute kidney injury	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.41% 6/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Bladder diverticulum	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Calculus urinary	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Chronic kidney disease	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders End stage renal disease	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Focal segmental glomerulosclerosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Glomerulonephritis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Hydronephrosis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Nephrolithiasis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Renal atrophy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Renal colic	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Renal cyst	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Renal failure	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Renal impairment	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Renal injury	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Stress urinary incontinence	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Ureterolithiasis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Urethral stenosis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Renal and urinary disorders Urinary retention	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Cervical polyp	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Cystocele	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Endometrial hyperplasia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Endometrial hypertrophy	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Endometrial thickening	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Genital prolapse	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Orchitis noninfective	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Uterine polyp	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Uterovaginal prolapse	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.27% 4/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.27% 4/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.41% 6/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.48% 7/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Cough	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.34% 5/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.28% 4/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.34% 5/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.69% 10/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	1.5% 22/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.48% 7/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.34% 5/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Rheumatoid lung	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Aortic intramural haematoma	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Aortic occlusion	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Aortic stenosis	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Aortitis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Circulatory collapse	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Deep vein thrombosis	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.48% 7/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Extremity necrosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Femoral artery embolism	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Haematoma	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Haemorrhage	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Hypertension	0.14% 2/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.21% 3/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Hypertensive crisis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Hypertensive emergency	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Hypertensive urgency	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Hypotension	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Hypovolaemic shock	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Iliac artery occlusion	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Labile blood pressure	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Peripheral artery occlusion	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Peripheral ischaemia	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.14% 2/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Peripheral vascular disorder	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Phlebitis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Shock	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Shock haemorrhagic	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Superior vena cava syndrome	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Thrombophlebitis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Thrombophlebitis superficial	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Thrombosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Varicose ulceration	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Varicose vein	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Vasculitis	0.07% 1/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Venous thrombosis	0.00% 0/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.07% 1/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Venous thrombosis limb	0.21% 3/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	0.00% 0/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.

Other adverse events

Measure	Tofacitinib 5 mg BID n=1455 participants at risk Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.	Tofacitinib 10 mg BID n=1456 participants at risk Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug.	TNFi n=1451 participants at risk In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug.
Blood and lymphatic system disorders Anaemia	5.2% 75/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	6.9% 100/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	5.0% 73/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Blood and lymphatic system disorders Lymphopenia	7.4% 107/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	10.4% 151/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	2.5% 36/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Diarrhoea	6.8% 99/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	5.6% 81/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	5.1% 74/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Gastrointestinal disorders Nausea	4.6% 67/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	6.6% 96/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	4.2% 61/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Bronchitis	15.2% 221/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	16.7% 243/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	11.6% 168/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Gastroenteritis	4.2% 61/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	5.2% 76/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	3.6% 52/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Herpes zoster	12.0% 175/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	11.0% 160/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	4.1% 59/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Influenza	6.3% 92/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	6.5% 95/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	4.9% 71/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Latent tuberculosis	6.1% 89/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	4.9% 72/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	6.5% 94/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Nasopharyngitis	11.5% 168/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	11.8% 172/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	11.3% 164/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Pharyngitis	6.0% 87/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	5.6% 81/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	5.2% 75/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Sinusitis	6.7% 97/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	5.6% 81/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	6.5% 94/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Upper respiratory tract infection	21.9% 319/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	21.8% 318/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	18.2% 264/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Infections and infestations Urinary tract infection	13.1% 190/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	15.1% 220/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	12.8% 186/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Injury, poisoning and procedural complications Fall	12.2% 177/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	11.0% 160/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	11.0% 159/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Investigations Alanine aminotransferase increased	4.6% 67/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	5.2% 75/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	3.3% 48/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Arthralgia	7.6% 111/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	6.2% 90/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	8.5% 124/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Back pain	6.9% 101/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	7.8% 113/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	7.7% 112/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.8% 84/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	4.9% 71/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	5.3% 77/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	12.6% 183/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	12.9% 188/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	13.9% 202/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Nervous system disorders Headache	3.4% 50/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	5.2% 75/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	4.4% 64/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 77/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	4.8% 70/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	5.0% 72/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.
Vascular disorders Hypertension	8.9% 129/1455 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	10.4% 152/1456 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.	8.8% 127/1451 • Baseline up to last contact date (maximum up to 72 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. SAS included all participants randomized in the study and received at least one dose of the randomized investigational drug. Total 153 deaths of which 152 were adjudicated and 1 occurred after the participant discontinued from the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER