Trial Outcomes & Findings for Open Label Study of Long Term Evaluation Against LDL-C Trial (NCT NCT01439880)

NCT ID: NCT01439880

Last Updated: 2022-09-21

Results Overview

Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1324 participants
• Primary outcome timeframe: 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.
• Results posted on: 2022-09-21

Participant Flow

This extension study was conducted at 188 centers in 18 countries. Participants were enrolled from one of five eligible phase 2 parent studies: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703). Participants were enrolled from October 2011 to June 2013.

Participants were randomized in a 2:1 ratio, irrespective of their treatment assignments during the phase 2 parent study, to either evolocumab plus standard of care (SOC) or SOC alone. Randomization was stratified by the treatment to which the participant was randomized to in the parent study, ie evolocumab or control.

Participant milestones

Measure	Standard of Care Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period). At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years in the all-investigational product \[all-IP\] period.	Evolocumab + SOC Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period). At week 52 participants continued treatment with evolocumab 420 mg QM for up to 4 years in the all-IP period.
SOC-controlled Period (Year 1) STARTED	442	882
SOC-controlled Period (Year 1) Received Evolocumab	0	881
SOC-controlled Period (Year 1) COMPLETED	398	822
SOC-controlled Period (Year 1) NOT COMPLETED	44	60
All-IP Period (Years 2 to 5) STARTED	398	822
All-IP Period (Years 2 to 5) Received Evolocumab	374	777
All-IP Period (Years 2 to 5) COMPLETED	328	682
All-IP Period (Years 2 to 5) NOT COMPLETED	70	140

Reasons for withdrawal

Measure	Standard of Care Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period). At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years in the all-investigational product \[all-IP\] period.	Evolocumab + SOC Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period). At week 52 participants continued treatment with evolocumab 420 mg QM for up to 4 years in the all-IP period.
SOC-controlled Period (Year 1) Withdrawal by Subject	24	38
SOC-controlled Period (Year 1) Death	2	1
SOC-controlled Period (Year 1) Sponsor Decision	0	1
SOC-controlled Period (Year 1) Lost to Follow-up	10	5
SOC-controlled Period (Year 1) Other	8	13
SOC-controlled Period (Year 1) Reason Missing	0	2
All-IP Period (Years 2 to 5) Lost to Follow-up	21	30
All-IP Period (Years 2 to 5) Withdrawal by Subject	30	66
All-IP Period (Years 2 to 5) Death	3	13
All-IP Period (Years 2 to 5) Sponsor Decision	1	0
All-IP Period (Years 2 to 5) Other	14	31
All-IP Period (Years 2 to 5) Reason Missing	1	0

Baseline Characteristics

Open Label Study of Long Term Evaluation Against LDL-C Trial

Baseline characteristics by cohort

Measure	Standard of Care n=442 Participants Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).	Evolocumab + SOC n=882 Participants Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).	Total n=1324 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 11.5 • n=5 Participants	56.9 years STANDARD_DEVIATION 11.6 • n=7 Participants	57.1 years STANDARD_DEVIATION 11.6 • n=5 Participants
Age, Customized < 65 years	307 Participants n=5 Participants	632 Participants n=7 Participants	939 Participants n=5 Participants
Age, Customized ≥ 65 years	135 Participants n=5 Participants	250 Participants n=7 Participants	385 Participants n=5 Participants
Sex: Female, Male Female	241 Participants n=5 Participants	459 Participants n=7 Participants	700 Participants n=5 Participants
Sex: Female, Male Male	201 Participants n=5 Participants	423 Participants n=7 Participants	624 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	39 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	429 Participants n=5 Participants	843 Participants n=7 Participants	1272 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	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	87 Participants n=5 Participants	168 Participants n=7 Participants	255 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	24 Participants n=5 Participants	54 Participants n=7 Participants	78 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White	325 Participants n=5 Participants	648 Participants n=7 Participants	973 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region North America	214 Participants n=5 Participants	441 Participants n=7 Participants	655 Participants n=5 Participants
Region Europe	133 Participants n=5 Participants	261 Participants n=7 Participants	394 Participants n=5 Participants
Region Asia Pacific	95 Participants n=5 Participants	180 Participants n=7 Participants	275 Participants n=5 Participants
Parent Study Baseline Low-density Lipoprotein Cholesterol (LDL-C) Concentration	144.6 mg/dL STANDARD_DEVIATION 37.4 • n=5 Participants	139.7 mg/dL STANDARD_DEVIATION 36.7 • n=7 Participants	141.3 mg/dL STANDARD_DEVIATION 37.0 • n=5 Participants
Stratification Factor: Parent Study Treatment Assignment Evolocumab once monthly (QM)	193 Participants n=5 Participants	387 Participants n=7 Participants	580 Participants n=5 Participants
Stratification Factor: Parent Study Treatment Assignment Evolocumab every 2 weeks (Q2M)	129 Participants n=5 Participants	256 Participants n=7 Participants	385 Participants n=5 Participants
Stratification Factor: Parent Study Treatment Assignment No evolocumab	120 Participants n=5 Participants	239 Participants n=7 Participants	359 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.

Population: All randomized participants (year 1) and randomized participants on study and who received at least 1 dose of evolocumab in the all-IP period (years 2-5).

Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.

Outcome measures

Measure	SOC-controlled Period: Standard of Care n=442 Participants Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).	SOC-controlled Period: Evolocumab + SOC n=882 Participants Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).	All-IP Period: SOC / Evolocumab + SOC n=374 Participants At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.	All-IP Period: Evolocumab + SOC / Evolocumab + SOC n=777 Participants At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.	Evolocumab in Parent Study: SOC Participants who received evolocumab in the parent study received standard of care treatment during the first year of the extension study.	Evolocumab in Parent Study: Evolocumab + SOC Participants who received evolocumab in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.
Number of Participants With Adverse Events All adverse events	327 Participants	728 Participants	342 Participants	718 Participants	—	—
Number of Participants With Adverse Events Adverse events ≥ grade 3	46 Participants	99 Participants	111 Participants	229 Participants	—	—
Number of Participants With Adverse Events Adverse events ≥ grade 4	2 Participants	11 Participants	8 Participants	28 Participants	—	—
Number of Participants With Adverse Events Serious adverse events	30 Participants	72 Participants	76 Participants	172 Participants	—	—
Number of Participants With Adverse Events AEs leading to discontinuation of evolocumab	0 Participants	28 Participants	16 Participants	27 Participants	—	—
Number of Participants With Adverse Events Fatal adverse events	0 Participants	0 Participants	1 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: Baseline of parent study and extension study weeks 24 and 52

Population: Participants randomized in study 20110110 and with available data at each time point.

Outcome measures

Measure	SOC-controlled Period: Standard of Care n=442 Participants Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).	SOC-controlled Period: Evolocumab + SOC n=882 Participants Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).	All-IP Period: SOC / Evolocumab + SOC n=120 Participants At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.	All-IP Period: Evolocumab + SOC / Evolocumab + SOC n=239 Participants At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.	Evolocumab in Parent Study: SOC n=322 Participants Participants who received evolocumab in the parent study received standard of care treatment during the first year of the extension study.	Evolocumab in Parent Study: Evolocumab + SOC n=643 Participants Participants who received evolocumab in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.
Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 Parent Study Baseline	144.6 mg/dL Standard Deviation 37.4	139.7 mg/dL Standard Deviation 36.7	147.7 mg/dL Standard Deviation 34.3	139.5 mg/dL Standard Deviation 33.6	143.4 mg/dL Standard Deviation 38.5	139.8 mg/dL Standard Deviation 37.8
Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 Week 24	136.9 mg/dL Standard Deviation 41.5	64.1 mg/dL Standard Deviation 33.3	142.5 mg/dL Standard Deviation 44.7	63.9 mg/dL Standard Deviation 34.6	134.8 mg/dL Standard Deviation 40.2	64.2 mg/dL Standard Deviation 32.9
Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 Week 52	140.5 mg/dL Standard Deviation 40.0	65.0 mg/dL Standard Deviation 34.4	143.1 mg/dL Standard Deviation 39.8	64.1 mg/dL Standard Deviation 33.2	139.4 mg/dL Standard Deviation 40.1	65.3 mg/dL Standard Deviation 34.9

SECONDARY outcome

Timeframe: Baseline of parent study and extension study weeks 24 and 52

Population: Participants randomized in the extension study 20110110 and with available data at each time point.

Outcome measures

Measure	SOC-controlled Period: Standard of Care n=442 Participants Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).	SOC-controlled Period: Evolocumab + SOC n=882 Participants Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).	All-IP Period: SOC / Evolocumab + SOC n=120 Participants At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.	All-IP Period: Evolocumab + SOC / Evolocumab + SOC n=239 Participants At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.	Evolocumab in Parent Study: SOC n=322 Participants Participants who received evolocumab in the parent study received standard of care treatment during the first year of the extension study.	Evolocumab in Parent Study: Evolocumab + SOC n=643 Participants Participants who received evolocumab in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 Parent Study Baseline	170.7 mg/dL Standard Deviation 43.0	165.1 mg/dL Standard Deviation 40.9	173.8 mg/dL Standard Deviation 39.6	165.5 mg/dL Standard Deviation 38.9	169.6 mg/dL Standard Deviation 44.2	165.0 mg/dL Standard Deviation 41.7
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 Week 24	161.4 mg/dL Standard Deviation 45.5	84.3 mg/dL Standard Deviation 37.7	166.9 mg/dL Standard Deviation 47.5	84.3 mg/dL Standard Deviation 39.0	159.4 mg/dL Standard Deviation 44.6	84.3 mg/dL Standard Deviation 37.3
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 Week 52	164.9 mg/dL Standard Deviation 44.5	85.3 mg/dL Standard Deviation 39.0	168.8 mg/dL Standard Deviation 45.3	85.0 mg/dL Standard Deviation 38.4	163.4 mg/dL Standard Deviation 44.1	85.4 mg/dL Standard Deviation 39.2

SECONDARY outcome

Timeframe: Baseline of parent study and extension study weeks 24 and 52

Population: Participants randomized in the extension study 20110110 and with available data at each time point.

Outcome measures

Measure	SOC-controlled Period: Standard of Care n=442 Participants Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).	SOC-controlled Period: Evolocumab + SOC n=882 Participants Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).	All-IP Period: SOC / Evolocumab + SOC n=120 Participants At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.	All-IP Period: Evolocumab + SOC / Evolocumab + SOC n=239 Participants At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.	Evolocumab in Parent Study: SOC n=322 Participants Participants who received evolocumab in the parent study received standard of care treatment during the first year of the extension study.	Evolocumab in Parent Study: Evolocumab + SOC n=643 Participants Participants who received evolocumab in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.
Apolipoprotein B Level at Week 24 and Week 52 Parent Study Baseline	113.2 mg/dL Standard Deviation 25.3	110.4 mg/dL Standard Deviation 23.8	115.4 mg/dL Standard Deviation 23.1	110.3 mg/dL Standard Deviation 22.4	112.4 mg/dL Standard Deviation 26.0	110.4 mg/dL Standard Deviation 24.3
Apolipoprotein B Level at Week 24 and Week 52 Week 24	107.9 mg/dL Standard Deviation 26.3	60.8 mg/dL Standard Deviation 23.3	110.5 mg/dL Standard Deviation 27.0	60.7 mg/dL Standard Deviation 23.9	106.9 mg/dL Standard Deviation 26.0	60.9 mg/dL Standard Deviation 23.1
Apolipoprotein B Level at Week 24 and Week 52 Week 52	109.5 mg/dL Standard Deviation 26.8	61.6 mg/dL Standard Deviation 23.5	110.7 mg/dL Standard Deviation 26.3	61.7 mg/dL Standard Deviation 23.0	109.1 mg/dL Standard Deviation 27.0	61.6 mg/dL Standard Deviation 23.7

SECONDARY outcome

Timeframe: Baseline of parent study and extension study weeks 24 and 52

Population: Participants randomized in the extension study 20110110 and with available data at each time point.

Outcome measures

Measure	SOC-controlled Period: Standard of Care n=442 Participants Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).	SOC-controlled Period: Evolocumab + SOC n=882 Participants Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).	All-IP Period: SOC / Evolocumab + SOC n=120 Participants At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.	All-IP Period: Evolocumab + SOC / Evolocumab + SOC n=239 Participants At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.	Evolocumab in Parent Study: SOC n=322 Participants Participants who received evolocumab in the parent study received standard of care treatment during the first year of the extension study.	Evolocumab in Parent Study: Evolocumab + SOC n=643 Participants Participants who received evolocumab in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.
Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 Parent Study Baseline	4.516 ratio Standard Deviation 1.617	4.386 ratio Standard Deviation 1.393	4.458 ratio Standard Deviation 1.345	4.388 ratio Standard Deviation 1.340	4.538 ratio Standard Deviation 1.708	4.386 ratio Standard Deviation 1.413
Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 Week 24	4.198 ratio Standard Deviation 1.536	2.603 ratio Standard Deviation 0.978	4.192 ratio Standard Deviation 1.408	2.594 ratio Standard Deviation 0.970	4.201 ratio Standard Deviation 1.584	2.607 ratio Standard Deviation 0.982
Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 Week 52	4.277 ratio Standard Deviation 1.652	2.626 ratio Standard Deviation 1.025	4.252 ratio Standard Deviation 1.434	2.622 ratio Standard Deviation 1.033	4.286 ratio Standard Deviation 1.733	2.628 ratio Standard Deviation 1.023

SECONDARY outcome

Timeframe: Baseline of parent study and extension study weeks 24 and 52

Population: Participants randomized in the extension study 20110110 and with available data at each time point.

Outcome measures

Measure	SOC-controlled Period: Standard of Care n=442 Participants Participants randomized to receive standard of care (SOC) treatment for the first year of the extension study (SOC-controlled period).	SOC-controlled Period: Evolocumab + SOC n=882 Participants Participants randomized to receive evolocumab 420 mg once a month plus standard of care for the first year of the extension study (SOC-controlled period).	All-IP Period: SOC / Evolocumab + SOC n=120 Participants At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.	All-IP Period: Evolocumab + SOC / Evolocumab + SOC n=239 Participants At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.	Evolocumab in Parent Study: SOC n=322 Participants Participants who received evolocumab in the parent study received standard of care treatment during the first year of the extension study.	Evolocumab in Parent Study: Evolocumab + SOC n=643 Participants Participants who received evolocumab in the parent study received subcutaneous evolocumab 420 mg QM plus standard of care during the first year of the extension study.
Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 Parent Study Baseline	0.759 ratio Standard Deviation 0.237	0.739 ratio Standard Deviation 0.217	0.764 ratio Standard Deviation 0.201	0.735 ratio Standard Deviation 0.212	0.757 ratio Standard Deviation 0.249	0.741 ratio Standard Deviation 0.218
Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 Week 24	0.717 ratio Standard Deviation 0.242	0.386 ratio Standard Deviation 0.178	0.715 ratio Standard Deviation 0.222	0.385 ratio Standard Deviation 0.183	0.718 ratio Standard Deviation 0.250	0.387 ratio Standard Deviation 0.176
Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 Week 52	0.726 ratio Standard Deviation 0.256	0.394 ratio Standard Deviation 0.185	0.719 ratio Standard Deviation 0.216	0.393 ratio Standard Deviation 0.186	0.729 ratio Standard Deviation 0.271	0.394 ratio Standard Deviation 0.185

Adverse Events

SOC-controlled Period: SOC

Serious events: 30 serious events

Other events: 217 other events

Deaths: 2 deaths

SOC-controlled Period: Evolocumab + SOC

Serious events: 72 serious events

Other events: 513 other events

Deaths: 1 deaths

All-IP Period: SOC / Evolocumab

Serious events: 78 serious events

Other events: 311 other events

Deaths: 3 deaths

All-IP Period: Evolocumab + SOC / Evolocumab

Serious events: 181 serious events

Other events: 626 other events

Deaths: 13 deaths

All-IP Period: Total

Serious events: 259 serious events

Other events: 937 other events

Deaths: 16 deaths

Serious adverse events

Measure	SOC-controlled Period: SOC n=442 participants at risk Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).	SOC-controlled Period: Evolocumab + SOC n=882 participants at risk Participants received evolocumab 420 mg once a month for the first year of the study (SOC-controlled period).	All-IP Period: SOC / Evolocumab n=398 participants at risk At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.	All-IP Period: Evolocumab + SOC / Evolocumab n=822 participants at risk At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.	All-IP Period: Total n=1220 participants at risk All participants in the All-IP period who received evolocumab 420 mg QM for up to 4 years.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute coronary syndrome	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina pectoris	0.45% 2/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.45% 4/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 9/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.82% 10/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina unstable	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve disease	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve disease mixed	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve incompetence	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve sclerosis	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve stenosis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial fibrillation	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.85% 7/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.74% 9/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial flutter	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial thrombosis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Bradycardia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac arrest	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure congestive	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiogenic shock	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiopulmonary failure	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery disease	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 4/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 6/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery embolism	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery occlusion	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery stenosis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve disease	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve disease mixed	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve incompetence	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial ischaemia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Nodal rhythm	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Pericarditis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Supraventricular tachycardia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ventricular extrasystoles	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ventricular tachycardia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Thyroid mass	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Thyroiditis acute	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Uterine prolapse	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cataract	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cataract cortical	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Corneal defect	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Eyelid ptosis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Keratitis	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Anal fistula	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Brunner's gland hyperplasia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Colitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dysphagia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Faecaloma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Faeces discoloured	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastritis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haemorrhoids	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Hiatus hernia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Ileus paralytic	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Inguinal hernia	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestine polyp	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Lumbar hernia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Obstructive pancreatitis	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Splenic artery aneurysm	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Tooth impacted	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest discomfort	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.45% 4/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.73% 6/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.57% 7/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Hypothermia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Mass	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Nodule	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Non-cardiac chest pain	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.45% 4/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.85% 7/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.57% 7/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Organ failure	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pain	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 4/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholelithiasis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 4/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.41% 5/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Jaundice	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Drug hypersensitivity	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess limb	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Anal abscess	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendiceal abscess	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendicitis	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.57% 5/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 3/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.41% 5/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Arthritis bacterial	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Arthritis infective	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bacterial pyelonephritis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bursitis infective	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis staphylococcal	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Chronic sinusitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Clostridial infection	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Clostridium difficile colitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cystitis	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Diverticulitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Endocarditis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Erysipelas	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Escherichia sepsis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis bacterial	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Groin abscess	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Herpes zoster	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infective spondylitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Joint abscess	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Meningitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Ophthalmic herpes simplex	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Osteomyelitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 3/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 4/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 6/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia bacterial	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelonephritis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 3/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Respiratory tract infection	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Rocky mountain spotted fever	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sepsis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Skin infection	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Streptococcal sepsis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Subcutaneous abscess	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 4/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Anaesthetic complication	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Cardiac contusion	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Intervertebral disc injury	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.23% 2/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Pulmonary contusion	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ulna fracture	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wound	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 3/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Electrocardiogram ST segment abnormal	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations HIV test positive	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Heart rate increased	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Hepatic enzyme increased	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Platelet count decreased	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Weight decreased	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dehydration	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 3/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Fluid retention	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Malnutrition	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 3/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 3/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Myalgia	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 3/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 9/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 14/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 3/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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 leukaemia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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 gastric	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Adenoma benign	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Anal squamous cell carcinoma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) B-cell lymphoma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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 neoplasm of bladder	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.61% 5/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 6/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Cholangiocarcinoma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 3/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Gastric cancer	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Hairy cell leukaemia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Hepatic cancer metastatic	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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 papilloma of breast	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Kaposi's sarcoma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Mantle cell lymphoma stage IV	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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 lung	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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 lymph nodes	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Myxoid liposarcoma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Oesophageal carcinoma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 4/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 6/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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 adenoma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Small cell lung cancer	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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) Small cell lung cancer metastatic	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Ataxia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Brain stem haemorrhage	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carotid artery stenosis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral thrombosis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular accident	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cervical radiculopathy	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness postural	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Encephalopathy	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Facial paralysis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Haemorrhage intracranial	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Lumbar radiculopathy	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Migraine	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Motor neurone disease	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Myelopathy	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Presyncope	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.23% 2/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Sciatica	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Spinal claudication	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Syncope	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.23% 2/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 4/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Tension headache	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Transient ischaemic attack	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Tremor	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Trigeminal neuralgia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Alcohol abuse	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Anxiety	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Confusional state	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Delirium	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Hallucination	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Mental status changes	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Psychotic disorder	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Suicidal ideation	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Acute kidney injury	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Bladder prolapse	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Hydronephrosis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nephrolithiasis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.36% 3/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal colic	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Ureterolithiasis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary incontinence	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.23% 2/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Cystocele	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Menorrhagia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.23% 1/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 4/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.50% 2/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.33% 4/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Laryngeal polyp	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.45% 2/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.49% 4/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.41% 5/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Sinus polyp	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Cholecystectomy	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Knee arthroplasty	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Medical device removal	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Accelerated hypertension	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic aneurysm	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic stenosis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.11% 1/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.25% 1/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Deep vein thrombosis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.24% 2/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.16% 2/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertensive crisis	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral ischaemia	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral vascular disorder	0.00% 0/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.12% 1/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.08% 1/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Measure	SOC-controlled Period: SOC n=442 participants at risk Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).	SOC-controlled Period: Evolocumab + SOC n=882 participants at risk Participants received evolocumab 420 mg once a month for the first year of the study (SOC-controlled period).	All-IP Period: SOC / Evolocumab n=398 participants at risk At week 52 participants began treatment with evolocumab 420 mg QM for up to 4 years during the all-IP period.	All-IP Period: Evolocumab + SOC / Evolocumab n=822 participants at risk At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.	All-IP Period: Total n=1220 participants at risk All participants in the All-IP period who received evolocumab 420 mg QM for up to 4 years.
Gastrointestinal disorders Diarrhoea	2.5% 11/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.6% 41/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.3% 33/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.4% 61/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.7% 94/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.9% 13/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 23/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 20/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.9% 32/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.3% 52/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	0.90% 4/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 23/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.8% 23/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.9% 32/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 55/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	1.1% 5/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.5% 31/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.0% 16/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.2% 43/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.8% 59/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	3.8% 17/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.4% 48/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.1% 40/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 94/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.0% 134/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cystitis	2.0% 9/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.7% 15/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.3% 25/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.7% 39/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.2% 64/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Influenza	5.4% 24/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.5% 57/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.8% 47/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.9% 81/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.5% 128/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Nasopharyngitis	14.5% 64/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.8% 148/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	30.7% 122/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	28.7% 236/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	29.3% 358/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sinusitis	3.4% 15/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.6% 32/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.8% 31/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.3% 68/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.1% 99/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	6.6% 29/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.2% 72/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 57/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.4% 118/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.3% 175/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	2.3% 10/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.7% 15/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.3% 25/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.3% 35/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.9% 60/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural pain	0.90% 4/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.45% 4/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 20/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.8% 23/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.5% 43/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	4.1% 18/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.7% 59/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	15.8% 63/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.3% 109/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.1% 172/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	5.0% 22/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.0% 62/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.8% 51/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	14.2% 117/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.8% 168/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle spasms	2.3% 10/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.8% 25/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.3% 21/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.7% 39/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.9% 60/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.7% 12/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.2% 28/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.8% 19/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.5% 62/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.6% 81/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.90% 4/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.5% 22/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 27/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.6% 54/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.6% 81/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). 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	3.2% 14/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 44/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.0% 32/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.5% 70/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.4% 102/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	2.7% 12/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.0% 18/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 20/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.2% 51/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.8% 71/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	2.7% 12/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.1% 54/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.0% 28/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.4% 44/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 72/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 19/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.6% 41/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.1% 40/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.4% 77/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.6% 117/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.3% 10/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.7% 24/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.5% 14/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 42/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.6% 56/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	4.5% 20/442 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 52/882 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.1% 40/398 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.0% 99/822 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 139/1220 • 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months. Adverse events are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the All-IP period (years 2-5). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER