Trial Outcomes & Findings for Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia (NCT NCT01854918)

Participant milestones
Measure	Standard of Care Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \[all-IP\] period.	Evolocumab + Standard of Care Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
SOC-controlled Period (Year 1) STARTED	1227	2454
SOC-controlled Period (Year 1) Received Evolocumab	5	2452
SOC-controlled Period (Year 1) COMPLETED	1197	2391
SOC-controlled Period (Year 1) NOT COMPLETED	30	63
All-IP Period (Years 2 and 3) STARTED	1197	2391
All-IP Period (Years 2 and 3) Received Evolocumab	1152	2291
All-IP Period (Years 2 and 3) COMPLETED	1079	2196
All-IP Period (Years 2 and 3) NOT COMPLETED	118	195

Reasons for withdrawal
Measure	Standard of Care Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \[all-IP\] period.	Evolocumab + Standard of Care Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
SOC-controlled Period (Year 1) Withdrawal by Subject	20	49
SOC-controlled Period (Year 1) Decision by Sponsor	2	1
SOC-controlled Period (Year 1) Lost to Follow-up	3	8
SOC-controlled Period (Year 1) Death	5	5
All-IP Period (Years 2 and 3) Withdrawal by Subject	78	117
All-IP Period (Years 2 and 3) Decision by Sponsor	8	11
All-IP Period (Years 2 and 3) Lost to Follow-up	27	51
All-IP Period (Years 2 and 3) Death	5	16

Baseline characteristics by cohort
Measure	Standard of Care n=1227 Participants Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \[all-IP\] period.	Evolocumab + Standard of Care n=2454 Participants Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.	Total n=3681 Participants Total of all reporting groups
Age, Continuous	58.8 years STANDARD_DEVIATION 10.7 • n=5 Participants	58.6 years STANDARD_DEVIATION 10.7 • n=7 Participants	58.7 years STANDARD_DEVIATION 10.7 • n=5 Participants
Age, Customized < 65 years	823 Participants n=5 Participants	1665 Participants n=7 Participants	2488 Participants n=5 Participants
Age, Customized ≥ 65 years	404 Participants n=5 Participants	789 Participants n=7 Participants	1193 Participants n=5 Participants
Sex: Female, Male Female	560 Participants n=5 Participants	1176 Participants n=7 Participants	1736 Participants n=5 Participants
Sex: Female, Male Male	667 Participants n=5 Participants	1278 Participants n=7 Participants	1945 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	58 Participants n=5 Participants	109 Participants n=7 Participants	167 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1169 Participants n=5 Participants	2345 Participants n=7 Participants	3514 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	152 Participants n=5 Participants	288 Participants n=7 Participants	440 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	49 Participants n=5 Participants	84 Participants n=7 Participants	133 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	1003 Participants n=5 Participants	2041 Participants n=7 Participants	3044 Participants n=5 Participants
Race/Ethnicity, Customized Other	16 Participants n=5 Participants	30 Participants n=7 Participants	46 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region North America	514 Participants n=5 Participants	1001 Participants n=7 Participants	1515 Participants n=5 Participants
Region Europe	504 Participants n=5 Participants	1018 Participants n=7 Participants	1522 Participants n=5 Participants
Region Asia Pacific	209 Participants n=5 Participants	435 Participants n=7 Participants	644 Participants n=5 Participants
Parent Study Baseline Low-density Lipoprotein Cholesterol (LDL-C) Concentration	125.8 mg/dL STANDARD_DEVIATION 49.3 • n=5 Participants	127.4 mg/dL STANDARD_DEVIATION 51.7 • n=7 Participants	126.9 mg/dL STANDARD_DEVIATION 50.9 • n=5 Participants

Outcome measures
Measure	Year 1: Standard of Care n=1227 Participants Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).	Year 1: Evolocumab + Standard of Care n=2454 Participants Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period). Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.	Years 2-3: SOC / Evolocumab + SOC n=1152 Participants At week 48, participants began treatment with evolocumab at a dose of either 140 mg Q2W or 420 mg QM, based on participant choice, plus SOC, for approximately 2 years during the all-IP period.	Years 2-3: Evolocumab + SOC / Evolocumab + SOC n=2291 Participants Participants continued to receive evolocumab plus SOC for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.
Number of Participants With Adverse Events All adverse events	796 Participants	1655 Participants	929 Participants	1789 Participants
Number of Participants With Adverse Events Adverse events ≥ grade 2	519 Participants	1070 Participants	700 Participants	1339 Participants
Number of Participants With Adverse Events Adverse events ≥ grade 3	124 Participants	225 Participants	214 Participants	379 Participants
Number of Participants With Adverse Events Adverse events ≥ grade 4	7 Participants	17 Participants	11 Participants	35 Participants
Number of Participants With Adverse Events Serious adverse events	104 Participants	195 Participants	178 Participants	332 Participants
Number of Participants With Adverse Events AEs leading to discontinuation of evolocumab	0 Participants	55 Participants	26 Participants	42 Participants
Number of Participants With Adverse Events Fatal adverse events	5 Participants	5 Participants	3 Participants	16 Participants
Number of Participants With Adverse Events Device related adverse events	0 Participants	57 Participants	25 Participants	45 Participants

Outcome measures
Measure	Year 1: Standard of Care n=1152 Participants Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).	Year 1: Evolocumab + Standard of Care n=2291 Participants Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period). Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.	Years 2-3: SOC / Evolocumab + SOC At week 48, participants began treatment with evolocumab at a dose of either 140 mg Q2W or 420 mg QM, based on participant choice, plus SOC, for approximately 2 years during the all-IP period.	Years 2-3: Evolocumab + SOC / Evolocumab + SOC Participants continued to receive evolocumab plus SOC for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.
Percent Change From Baseline in LDL-C at Weeks 48 and 104 Week 48	7.43 percent change Standard Deviation 38.93	-51.59 percent change Standard Deviation 28.88	—	—
Percent Change From Baseline in LDL-C at Weeks 48 and 104 Week 104	-49.96 percent change Standard Deviation 33.29	-50.31 percent change Standard Deviation 30.34	—	—

Outcome measures
Measure	Year 1: Standard of Care n=1152 Participants Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).	Year 1: Evolocumab + Standard of Care n=2291 Participants Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period). Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.	Years 2-3: SOC / Evolocumab + SOC At week 48, participants began treatment with evolocumab at a dose of either 140 mg Q2W or 420 mg QM, based on participant choice, plus SOC, for approximately 2 years during the all-IP period.	Years 2-3: Evolocumab + SOC / Evolocumab + SOC Participants continued to receive evolocumab plus SOC for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.
Change From Baseline in LDL-C at Weeks 48 and 104 Week 48	0.4 mg/dL Standard Deviation 43.9	-68.8 mg/dL Standard Deviation 46.6	—	—
Change From Baseline in LDL-C at Weeks 48 and 104 Week 104	-66.4 mg/dL Standard Deviation 50.1	-67.2 mg/dL Standard Deviation 46.6	—	—

Serious adverse events
Measure	Year 1: Standard of Care n=1227 participants at risk Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).	Year 1: Evolocumab + Standard of Care n=2454 participants at risk Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period). Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.	Years 2-3: SOC / Evolocumab + SOC n=1197 participants at risk At week 48, participants began treatment with evolocumab at a dose of either 140 mg Q2W or 420 mg QM, based on participant choice, plus SOC, for approximately 2 years during the all-IP period.	Years 2-3: Evolocumab + SOC / Evolocumab + SOC n=2391 participants at risk Participants continued to receive evolocumab plus SOC for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.	Years 2-3: Total n=3588 participants at risk All participants in the All-IP period who received evolocumab plus SOC for approximately 2 years. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.
Infections and infestations Sepsis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Septic shock	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sinusitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina unstable	0.49% 6/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.29% 7/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.46% 11/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.42% 15/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve disease	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Haemolysis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute coronary syndrome	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute myocardial infarction	0.33% 4/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 8/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 12/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.42% 15/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina pectoris	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.29% 7/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.84% 10/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 8/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 18/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve incompetence	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve sclerosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Arrhythmia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Arteriosclerosis coronary artery	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial fibrillation	0.24% 3/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.58% 7/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.29% 7/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.39% 14/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial flutter	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrioventricular block	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Bradycardia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac arrest	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure acute	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure congestive	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 6/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery disease	0.33% 4/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 3/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.29% 7/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 9/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery occlusion	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Left ventricular failure	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve incompetence	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial infarction	0.16% 2/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 5/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial ischaemia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Palpitations	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Pericardial effusion	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Pericarditis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Rheumatic heart disease	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Sinus node dysfunction	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Supraventricular tachycardia	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tachycardia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ventricular extrasystoles	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ventricular fibrillation	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ventricular tachycardia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Congenital, familial and genetic disorders Adenomatous polyposis coli	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Tinnitus	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Malaise	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Vertigo	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Vertigo positional	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Goitre	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hyperparathyroidism primary	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hyperthyroidism	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hypothyroidism	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Blindness transient	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Multiple organ dysfunction syndrome	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cataract	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Macular fibrosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Retinal vein occlusion	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal hernia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 3/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Anal skin tags	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticulum intestinal	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Duodenitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Enterovesical fistula	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric ulcer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastritis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastroduodenal ulcer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Hiatus hernia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Ileus	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Inguinal hernia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal perforation	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intussusception	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestine perforation	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestine polyp	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Staphylococcal infection	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Mechanical ileus	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophagitis	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis acute	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Salivary gland calculus	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Short-bowel syndrome	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Umbilical hernia	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest discomfort	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	0.16% 2/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Complication associated with device	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Face oedema	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Gait disturbance	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Impaired healing	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site erythema	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Non-cardiac chest pain	0.24% 3/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 4/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.84% 10/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 8/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 18/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Oedema peripheral	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pain	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Polyp	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Sudden death	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Vascular stent occlusion	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Vascular stent stenosis	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Bile duct stone	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholangitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis chronic	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholelithiasis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 3/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.42% 5/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Gallbladder necrosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatic function abnormal	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Non-alcoholic fatty liver	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Sphincter of Oddi dysfunction	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Allergy to arthropod sting	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Anaphylactic reaction	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Contrast media allergy	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Drug hypersensitivity	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Hypersensitivity	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abdominal abscess	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess jaw	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess neck	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendicitis	0.16% 2/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendicitis perforated	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Arthritis bacterial	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchopulmonary aspergillosis	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Campylobacter infection	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Clostridium difficile infection	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cystitis	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Device related infection	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Herpes zoster	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Diverticulitis	0.16% 2/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Endocarditis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Epididymitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis bacterial	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis viral	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Haematoma infection	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Hepatitis B	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infected dermal cyst	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Influenza	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Intervertebral discitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Liver abscess	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Localised infection	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lower respiratory tract infection	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Meningitis viral	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Neurosyphilis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Osteomyelitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Otitis externa	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Parotitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pelvic inflammatory disease	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Peritonitis	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 12/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.45% 16/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia pneumococcal	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia viral	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Post procedural infection	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Postoperative abscess	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Postoperative wound infection	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelonephritis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelonephritis acute	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypoglycaemic seizure	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural fever	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Intracranial aneurysm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subdural haematoma	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tendon rupture	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Ischaemic stroke	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications VIIIth nerve injury	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Vascular graft complication	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Vascular graft stenosis	0.16% 2/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Alanine aminotransferase increased	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Anticoagulation drug level below therapeutic	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Antimitochondrial antibody positive	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Antinuclear antibody	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Aspartate aminotransferase increased	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood immunoglobulin M increased	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Ejection fraction decreased	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Intraocular pressure increased	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Liver function test abnormal	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Red blood cell sedimentation rate increased	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Scan myocardial perfusion abnormal	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dehydration	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Fluid overload	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Gout	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebellar haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyponatraemia	0.16% 2/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Obesity	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Face injury	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bursitis	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Lacunar infarction	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Diffuse idiopathic skeletal hyperostosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Femoroacetabular impingement	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 6/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 6/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 12/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Lumbar radiculopathy	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Knee deformity	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 6/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Femoral neck fracture	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Metabolic encephalopathy	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.41% 5/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 12/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.8% 22/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.92% 22/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.2% 44/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign anorectal neoplasm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Migraine	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 3/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.33% 4/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Myelopathy	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Ataxia	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carotid artery aneurysm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Duodenal neoplasm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential thrombocythaemia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carotid artery stenosis	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive papillary breast carcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm of appendix	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral papilloma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral ischaemia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary tumour of renal pelvis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile neoplasm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.16% 2/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 3/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Humerus fracture	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular accident	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.29% 7/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland adenoma	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cervical radiculopathy	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dysaesthesia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Epilepsy	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the vulva	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular seminoma (pure)	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Tonsillitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urosepsis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Haemorrhage intracranial	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Anastomotic complication	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ankle fracture	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Back injury	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Cartilage injury	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Comminuted fracture	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Concussion	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Haemorrhagic stroke	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fractured coccyx	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hydrocephalus	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Artery dissection	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Haematuria	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypoaesthesia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Incision site haematoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Intestinal anastomosis complication	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Joint dislocation	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Laceration	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Overdose	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary incontinence	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Cystocele	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Genital prolapse	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Mastoptosis	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Prostatic obstruction	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Prostatism	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Prostatitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Rectocele	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Uterine polyp	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acquired diaphragmatic eventration	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchostenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.16% 2/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.16% 2/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin lesion	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Accelerated hypertension	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic aneurysm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic dilatation	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic dissection	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Arteriosclerosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Blood pressure fluctuation	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Deep vein thrombosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Haematoma	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	0.16% 2/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertensive crisis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertensive emergency	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypotension	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Labile blood pressure	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Malignant hypertension	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Microangiopathy	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Orthostatic hypotension	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Pelvic venous thrombosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral artery aneurysm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral artery occlusion	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral ischaemia	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral vascular disorder	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Subclavian artery stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Thrombophlebitis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Varicose vein	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Venous thrombosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Venous thrombosis limb	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Nerve root compression	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Paresis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Polyneuropathy	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Presyncope	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Sciatica	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Seizure	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Spinal cord haematoma	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Syncope	0.24% 3/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 2/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.20% 7/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Transient global amnesia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Transient ischaemic attack	0.24% 3/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.22% 8/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Tremor	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Visual field defect	0.08% 1/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Product Issues Device leakage	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Agoraphobia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Alcoholism	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Bipolar I disorder	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Bipolar disorder	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Completed suicide	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Confusional state	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 4/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Drug dependence	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Psychotic disorder	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Schizophrenia	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Suicidal ideation	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Suicide attempt	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Acute kidney injury	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Bladder fibrosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Calculus bladder	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Calculus urinary	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 3/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Chronic kidney disease	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Hydronephrosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nephrolithiasis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 4/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.14% 5/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal artery stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal cyst	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal failure	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal impairment	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal infarct	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Ureteral spasm	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Ureteric stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Ureterolithiasis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 3/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 2/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.06% 2/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urethral stenosis	0.00% 0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2454 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1197 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2391 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.03% 1/3588 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Infections and infestations

Sepsis

0.00%

0/1227 • 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period.